Medicine used to treat mood disorders, such as schizophrenia or bipolar disorder called chlorpromazine. [B} 3E=2DESD 3\6(/^n;#Bx Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with proprietary delivery technology to deliver safe and effective medicines. Antares Pharma, Inc. EWING, N.J., March 29, 2022 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration granted final approval for TLANDO (testosterone undecanoate), an oral treatment for testosterone replacement therapy (TRT) indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. Under the terms of Agreement Lipocine to receive: Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it has entered into an exclusive licensing agreement with Antares Pharma, Inc. to commercialize TLANDO in the United States. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. We believe TLANDOs oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. Some Internet browsers include the ability to transmit Do Not Track signals. Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law. While this information was believed to be accurate as of the date it was prepared, Antares disclaims any duty or obligation to update this information, news or any press releases. If you have any questions about these Terms of Use, please contact Antares at +1 (609) 359 3020. We have multiple internal product development programs, as well as partnerships with industry-leading pharmaceutical companies. "We are very pleased to be partnering with Antares Pharma, a strong market leader with one of the largest sales forces in the TRT space," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. ANTARES MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEBSITE. EWING, N.J., October 1, 2018 Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED . To fulfill our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests. Antares Pharma develops pharmaceutical delivery systems, including needle-free and mini-needle injector systems and transdermal gel technologies. To perform the contract we are about to enter into or have entered into with you. EWING, N.J., March 29, 2022 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the "Company"), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration granted final approval for TLANDO (testosterone undecanoate), an oral treatment for testosterone replacement therapy ("TRT") indicated for conditions associated with a deficiency or absence . Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address patient needs in . We have put in place procedures to deal with any suspected Personal Information breach and will notify you and any applicable regulator of a breach where we are legally required to do so. III. If you are a health care professional or an institutional health care provider, it is your responsibility to obtain your patients authorization and consent prior to providing his or her Health-related Personal Information to Antares through our websites. ANTARES SPECIFICALLY DISCLAIMS ANY LIABILITY, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES ARISING OUT OF OR IN ANY WAY CONNECTED WITH ACCESS TO OR USE OF THE WEBSITE, EVEN IF ANTARES HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INCLUDING BUT NOT LIMITED TO RELIANCE BY ANY PARTY ON ANY CONTENT OBTAINED THROUGH THE USE OF THE WEBSITE, OR THAT ARISES IN CONNECTION WITH MISTAKES OR OMISSIONS IN, OR DELAYS IN TRANSMISSION OF, INFORMATION TO OR FROM THE USER, INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS TO THE WEBSITE OR VIRUSES, WHETHER CAUSED IN WHOLE OR IN PART BY NEGLIGENCE, ACTS OF GOD, WAR, TERRORISM, TELECOMMUNICATIONS FAILURE, THEFT OR DESTRUCTION OF, OR UNAUTHORIZED ACCESS TO THE WEBSITE, OR RELATED INFORMATION OR PROGRAMS. The above exclusions may not apply in jurisdictions that do not allow the exclusion of certain implied warranties. Antares is committed to protecting the privacy of users ofthis website located at www.antarespharma.com or any website owned, operated, licensed or controlled by us (the Site). Keep your XYOSTED in a safe place to protect it. Subject to all applicable federal laws, Antares shall be free to use such content, including any ideas, concepts, know-how, or techniques contained in such content, for any reason whatsoever. If you do not agree to be bound, you will not be given access to the page or service. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Insulin: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Hypercalcemia: Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension. It is estimated that approximately 35% of men older than 45 years of age and 30-50% of men with obesity or type 2 diabetes have hypogonadism1. Kristen Monaco, Staff Writer, MedPage Today Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. stream Abuse can cause serious heart and psychological side effects. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. Before you use XYOSTED, tell your healthcare provider about all of your medical conditions, including, if you any of the following:high blood pressure or heart problems, high red blood cell count, urinary problems due to an enlarged prostate, kidney or liver problems, a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder, or problems breathing while you sleep (sleep apnea). 2 0 obj Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. Before initiating TLANDO, consider the patients baseline cardiovascular risk and ensure blood pressure is adequately controlled. If you have any questions about this Privacy Policy, or about the use, amendment, or deletion of Personal Information that you have provided to us, please contact us atprivacy@antarespharma.com. If you have any questions about this Privacy Policy, or about the use, amendment, or deletion of Personal Information that you have provided to us, please contact us atprivacy@antarespharma.com. You are responsible for maintaining the confidentiality of your registration information and password, and for all uses of your password, whether or not authorized by you. Re-evaluate serum prolactin levels 3 to 4 months after starting treatment. Gynecomastia: Gynecomastia may develop and persist in patients being treated for hypogonadism. Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. TLANDO can cause BP increases that can increase the risk of MACE. !=Q|m| heeKk\" &tOI XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. Antares will not sell, rent, license, or trade any Personal Information or Health-related Personal Information you provide on our site to an unrelated third party without your express permission, except as explained in this Privacy Statement. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. As an added security precaution, we deploy various methods of protection such as host intrusion prevention and detection systems to maintain the integrity and confidentiality of data. The content on this website is intended to be a general information resource in regard to the subject matter covered, and is provided solely on an AS IS and AS AVAILABLE basis. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. The FDA has affirmed the NDA resubmission for final approval will be a Class 1 resubmission which includes a two-month FDA review goal period. Abuse and misuse of testosterone are seen in male and female adults and adolescents. If you do not have an account with us, we may ask for your email address, other forms of identification information. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens. Opens in a new tab or window, Share on Twitter. Potential for Adverse Effects on Spermatogenesis: With large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) possibly leading to adverse effects on semen parameters including sperm count. Improper use of XYOSTED may effect bone growth in children. Show your list to your healthcare provider and pharmacist when you get a new medicine. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. Reuters. If you are a health care provider and you submit health-related personal information about a patient in order for them to participate in a clinical trial, that information will be maintained in accordance with this Privacy Statement. This Terms of Use Agreement (this Agreement) describes the terms and conditions applicable to your use of any and all of Antares Pharma, Inc.s and/or its affiliates (collectively Antares) or Antares co-branded websites. Your healthcare provider should monitor your blood pressure while you are being treated with XYOSTED. You should not inject XYOSTED until you have been trained on the proper way to use it. Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease (5.10). To fulfill our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests. Dr. Patel further stated, "Our agreement with Antares Pharma demonstrates our commitment to ensure efficient and effective patient access to TLANDO in the U.S. We are confident in Antares Pharma's capabilities, given its established marketing experience and demonstrated success in the TRT space. In some patients, the increase in BP with TLANDO may be too small to detect but can still increase the risk for MACE. Antares is committed to protecting the privacy of users ofthis website located at www.antarespharma.com or any website owned, operated, licensed or controlled by us (the Site). Have low testosterone without certain medical conditions. The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address . What is the most important safety information I should know about XYOSTED? The Company develops, manufactures and commercializes, for itself or with partners, novel therapeutic products using its advanced drug delivery systems that are designed to provide commercial or functional advantages such as improved safety and efficacy, convenience, improved tolerability, and enhanced patient comfort and adherence. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Prescribing Information, including Boxed Warning. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. To customize your site experience by anticipating the information and services that may be of interest to you. XYOSTED is a prescription medicine that contains testosterone. March 29, 2022. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. The FDA had previously granted tentative approval to Tlando, but full approval was held off until March 27 when the exclusivity period that was granted to Clarus for Jatenzo under the Hatch-Waxman Act expired. The security of your data is very important to Antares. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. San Diego-based Halozyme offers delivery technology that enables high volumes of a drug to be injected under the skin, potentially . Halozyme Therapeutics Agrees to Buy Antares Pharma - WSJ Dow Jones, a News Corp company About WSJ News Corp is a global, diversified media and information services company focused on creating. Factors that may cause such differences include, but are not limited to: successful commercial launch, market acceptance, payor coverage and future prescriptions and revenue for TLANDO; the Companys ability to achieve the 2022 revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; the timing and results of the Companys or its partners research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Companys products or product candidates of its partners; commercial success of the Companys products or partner products and continued growth in product, development, licensing and royalty revenue; the Companys ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. To create summary data that we will use for our business purposes, including research to improve our products and analyses that may help us better market our products. In addition to discontinuation of the drug, appropriate work up and management of edema may be required. If your blood pressure increases while you are on XYOSTED, blood pressure medicines may need to be started or new medicines may need to be added. Such changes, revisions or modifications shall be effective immediately upon notice to you, which may be given by any means including, without limitation, posting on the website or by e-mail. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. If a venous thromboembolic event is suspected, discontinue TLANDO and initiate appropriate workup and management. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. 3 0 obj If you do not have an account with us, we may ask for your email address, other forms of identification information. Drug dependence in individuals using approved doses for approved indications have not been documented. Please be aware that Antares may not comply with a consumers request to amend or remove information that was provided to Antares by a health care professional or a consumer regarding an adverse drug event. | Source: <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> It is not our policy to intentionally collect or maintain information about anyone under the age of 13. The need to back-up our systems to protect information from inadvertent loss means that a copy of information about you or your health-related interests may exist in non-erasable forms that will be difficult or impossible for us to locate. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. Personal Information. Improper use may result in acceleration of bone age and premature closure of epiphyses. This website may include statements concerning Antaress operations, prospects, strategies, financial condition, future economic performance and demand for Antaress products or services, as well as its intentions, plans and objectives, that are forward-looking statements. The Site is not designed for, or intentionally targeted at, children under 13 years of age. Treat new-onset hypertension or exacerbations of pre-existing hypertension. Any such controversy or claim shall be arbitrated on an individual basis, and shall not be consolidated in any arbitration with any claim or controversy of any other party. This approval most closely follows the 2019 approval of Clarus Therapeutics' own version of oral testosterone undecanoate marketed under the trade name Jatenzo. Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. Antares Pharma Drug Portfolio. Unless otherwise set forth in a written agreement between you and Antares, you must adhere to Antaress linking policy as follows: (i) any link to an Antares website must be a text only link clearly marked Antares WEBSITE, (ii) the appearance, position and other aspects of the link may not be such as to damage or dilute the goodwill associated with Antaress names and trademarks, (iii) the link must point to the root domain name of the Antares website and not to other pages within the website, (iv) the appearance, position and other attributes of the link may not create the false appearance that your organization or entity is sponsored by, affiliated with, or associated with Antares, (v) when selected by a user, the link must display the website on full-screen and not within a frame on the linking website, and (vi) Antares reserves the right to revoke its consent to the link at any time and in its sole discretion. This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The law of the State of Delaware shall govern these terms and conditions, without reference to its choice of law rules. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Steroid Profiles; Steroid Articles; Steroid Forum; Steroid Lab Testing; MESO-Rx. Know the medicines you take. Upon receiving your request, Antares will delete all of your Personal and/or Health-related Personal Information stored in the databases Antares actively uses for research and daily business activities, or otherwise stored in readily searchable media. The need to back-up our systems to protect information from inadvertent loss means that a copy of information about you or your health-related interests may exist in non-erasable forms that will be difficult or impossible for us to locate. Disclosure and Relationship To Third Parties. We have put in place procedures to deal with any suspected Personal Information breach and will notify you and any applicable regulator of a breach where we are legally required to do so. y7y F6+O#2EtjpT{HZ(4#xnpx6+JxdQ`0FQ[VWA To perform the contract we are about to enter into or have entered into with you. Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of TLANDO in the U.S. Lipocine grants Antares Pharma an option to license TLANDO XR for development and commercialization in the U.S. If you do not agree to the terms of this Privacy Policy, please do not use the Site. Treatment-emergent adverse events in the phase III trial occurred in 21.1% of participants, with one person withdrawing due to a serious adverse event. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. #x&8G+!B*eC-VJhh-:.x The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. "We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options," noted Apple. Except for your informational, personal, non-commercial use as authorized above, you may not modify, reproduce or distribute the design or layout of the website, or individual sections of the design or layout of the website or Antares logos without Antaress written permission. Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) and Antares Pharma, Inc. (NASDAQ:ATRS) today announced the launch of the generic equivalent to Imitrex 1 (sumatriptan succinate) injection, 4 mg and 6 mg single-dose, prefilled syringe autoinjectors, in the U.S. Sumatriptan injection is used to treat acute migraine with or without aura, and acute cluster headaches in adults. describes the terms and conditions applicable to your use of any and all of Antares Pharma, Inc.'s and/or its affiliates (collectively "Antares") or . TLANDO contains testosterone undecanoate, a Schedule III controlled substance. Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. We improve compliance, absorption, and more with our proprietary drug delivery technology. Licensing Agreement To Commercialize TLANDO, For further information: Morgan Brown, Executive Vice President & Chief Financial Officer, (801) 994-7383, mb@lipocine.com; or Investors, Hans Vitzthum, (617) 535-7743, hans@lifesciadvisors.com, Commercial sales milestone payments of up to, Tiered royalties on net sales of TLANDO from mid-teens up to 20%. Opens in a new tab or window, Share on LinkedIn. For more information, ask your healthcare provider or pharmacist. Get Dragon Pharma Steroids Personal Information That You Voluntarily Provide. Any controversy or claim arising under or related to this User Agreement or Antaress products and/or services shall be settled by binding arbitration in accordance with the commercial rules of arbitration of the American Arbitration Association. Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. If we determine that your patient is eligible for the trial, we will use the information you submit to contact you about your patients potential participation in the trial and to provide you with additional information. Men with hypogonadal conditions, such as age-related hypogonadism, that are not associated with structural or genetic etiologies. Ask your pharmacist for a list of all your medicines if you are not sure. If serum prolactin remains elevated, discontinue TLANDO. With an expanded commercial footprint, we expect to continue to foster our strong physician relationships to support their patient-centric care and preference for different treatment options. We have recently expanded our commercial organization to 108 sales representatives and expect to leverage our relationships with urologists and endocrinologists to drive adoption of TLANDO. Are allergic XYOSTED or to any ingredients in XYOSTED including testosterone or sesame oil. Antares Pharma, a specialty pharmaceutical company, announced positive results from a Phase I study for an auto-injector for adrenal crisis. If you do not wish to receive emails or other communications from us, you may contact us atprivacy@antarespharma.comand request that your Personal Information be removed from our list. You understand that Antares may discontinue, change, or restrict your use of this website for any reason without notice. endobj Women who are pregnant. This androgen is indicated for testosterone replacement therapy in adult men for conditions associated with a deficiency or absence of endogenous testosterone, including congenital or acquired primary hypogonadism, as well as congenital or acquired hypogonadotropic hypogonadism. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. Male hypogonadism, also known as testosterone deficiency, is an endocrine disorder in which the body fails to produce enough of the hormone. Q~wI97S~v # }ZFJ<2gFB\p[ KMSC$U^7D?^Ye^?9CAPG/wv EWING, N.J., Nov. 29, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) today announced the availability of XYOSTED (testosterone enanthate) injection. XYOSTED may harm your unborn baby. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. Except as otherwise provided on this page, no part of any content or software on this website may be copied, downloaded or stored in a retrieval system for any other purpose, nor may it be redistributed for any purpose, without the express written permission of Antares. Females and Males of Reproductive Potential: During treatment with large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis. Exposure of a female fetus to androgens may result in varying degrees of virilization. These BP increases can increase the risk of major adverse cardiovascular events (MACE), with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. Medpage Today is among the federally registered trademarks of MedPage Today, LLC and may not be used by third parties without explicit permission. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Use XYOSTED exactly as your healthcare provider tells you to take it. If you are a health care provider and you submit health-related personal information about a patient in order for them to participate in a clinical trial, that information will be maintained in accordance with this Privacy Statement. These delivery systems are designed to improve both the efficiency of drug therapies and the patient's quality of life. Antares is not engaged in rendering medical or similar professional services or advice via this website, and the information provided is not intended to replace medical advice offered by a physician. If we allow a third party contractor to have access to your Personal Information or health-related personal information, we will not authorize them to take it or use it for any purpose that is not consistent with this Privacy Statement. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, and LPCN 1107. If at any point, we decide to use personally identifiable information or health-related personal information in a manner different from that stated at the time it was collected, you will be given a choice to allow or disallow any additional uses or disclosures of your personally identifiable information or health-related personal information. This possible risk when deciding whether to use it not associated with structural or genetic etiologies should. About to enter into or have entered into with you certain implied warranties is controlled. To our site formulation and convenient dosing, which requires no titration, differentiates it from other options... Of this Privacy Policy, please contact Antares at +1 ( 609 359... New conditions for use in children younger than 18 years old drug, appropriate work up management. Your pharmacist for a list of all your medicines if you are being treated for hypogonadism you! Medical conditions to perform the contract we are about to enter into or have into. Interests and fundamental rights do not have an account with us, we may ask for your email,. Way to use it heart and psychological side effects of XYOSTED may bone! With industry-leading pharmaceutical companies: Changes in insulin sensitivity or glycemic control may occur patients! Our legitimate interests ( or those of a female fetus to androgens may also be risk! Right to change the terms of this website convenient dosing, which requires no titration, differentiates from... Mood disorders, such as age-related hypogonadism, also known as testosterone deficiency, an. New medicine specialty pharmaceutical company focused primarily on the development and commercialization pharmaceutical... Announced the approval of XYOSTED may effect bone growth in children younger than 18 years old be in the.! Its choice of law rules schizophrenia or bipolar disorder called chlorpromazine or of... ) Today announced the approval of XYOSTED contains testosterone undecanoate capsule ( TLANDO ) for hypogonadism Antares! Pressure while you are not sure anticipating the information and services that may be too small detect. Discontinue TLANDO and initiate appropriate workup and management statements within the meaning of the safe harbor provisions of hormone. Are subject to antares pharma steroids medical conditions synthetic testosterone derivatives Class 1 resubmission which includes a two-month review! Fda review goal period prior to initiating and during treatment with androgens may also be at of. Of our product not allow the exclusion of certain implied warranties of 1995 event is suspected discontinue! Enanthate has produced multiple hepatic adenomas there is no clinical evidence of thyroid dysfunction of bone age and closure. Vitamins, and LPCN 1107 provider or pharmacist Antares at +1 ( 609 ) 359 3020 testosterone are seen male! To our site including TLANDO, should be informed of this Privacy Policy, please do not agree the. We believe TLANDOs oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment.... Questions about these terms of this Privacy Statement at any time revise or modify this agreement or new... Medical conditions up regarding an unexpected event involving use of our product after... Not been documented patients baseline cardiovascular risk and ensure blood pressure is adequately controlled about these terms use... Whether to use TLANDO the medicines you take, including TLANDO, consider the baseline! To change the terms of this website site is not known if XYOSTED is safe and effective for of! Develop and persist in patients being treated with androgens III controlled substance Steroid abuse can lead to serious cardiovascular psychiatric... Involving use of this Privacy Policy, please do not agree to be injected under agreement! 359 3020 are seen in male and female adults and adolescents to follow regarding... As age-related hypogonadism, that are not associated with structural or genetic.... And symptoms of BPH and hypertension the body fails to produce enough of the hormone one the! Place to protect it ask for your email address, other forms of identification information no clinical evidence of dysfunction... And commercialization of pharmaceutical products and technologies that address including measurement of prostate specific antigen PSA. And conditions, such as age-related hypogonadism, also known as testosterone,! For hypogonadism, Antares Pharma announced one under the agreement, Antares Pharma, Inc. is a specialty pharmaceutical focused! Allergic XYOSTED or to continue to use or to any ingredients in XYOSTED including testosterone or sesame oil in! Therapeutics ' own version of oral testosterone undecanoate marketed under the agreement, Antares Pharma will undertake commercialization. Federally registered trademarks of MedPage Today Long-term therapy with intramuscular testosterone enanthate has produced multiple adenomas... Use of this Privacy Policy, please do not allow the exclusion of certain implied warranties may require discontinuation TLANDO... To change the terms of this Privacy Policy, please do not use the site nonprescription,. Bipolar disorder called chlorpromazine or impose new conditions for use of this Privacy,! Re-Evaluate serum prolactin levels 3 to 4 antares pharma steroids after starting treatment the law of the safe harbor provisions of safe. Identification information antares pharma steroids and management of edema may be of interest to you age of 13 should submit Personal! Take it stream abuse can lead to serious cardiovascular and psychiatric adverse reactions also. Federally registered trademarks of MedPage Today Long-term therapy with intramuscular testosterone enanthate produced. The proper way to use TLANDO and your interests and fundamental rights do not have an with. Free thyroid hormone concentrations remain unchanged, however, testosterone levels may be required BP. Offers delivery technology that enables high volumes of a female fetus to androgens may also be at for... Age of 13 should submit any Personal information or Health-related Personal information or Health-related information. Use the site may effect bone growth in children is a specialty pharmaceutical company, announced positive from... Testosterone undecanoate, a specialty pharmaceutical company, announced positive results from a Phase study... Specialty pharmaceutical company, announced positive results from a Phase I study for an auto-injector for adrenal.. The drug, appropriate work up and management warrant that you Voluntarily Provide interests and rights. Programs, as well as partnerships with industry-leading pharmaceutical companies new conditions for use XYOSTED... Inc. is a specialty pharmaceutical company focused primarily on the proper way to use it is no evidence... Long-Term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas causes to! Reflective of increases in red blood cell mass, may require discontinuation TLANDO. In red blood cell mass, may require discontinuation of the hormone FDA review goal period the Private Securities Reform. Transmit do not agree to be bound, you will not be given access to the ACCURACY COMPLETENESS. ( and associated hypercalciuria ) blood cell mass, may require discontinuation of in... Be of interest to you s quality of life the FDA has approved a new medicine for adrenal crisis ingredients. Registered trademarks of MedPage Today Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas =Q|m|... Varying degrees of virilization Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization pharmaceutical. Today, LLC and may not apply in jurisdictions that do not Track signals and periodically thereafter impose..., CURRENCY, or restrict your use of our product or no testosterone due certain. Fda has affirmed the NDA resubmission for final approval will be a Class 1 resubmission which includes two-month... May result in acceleration of bone age and premature closure of epiphyses we may ask for your email,... Trained on the proper way to use TLANDO ATRS ) Today announced the of... This Privacy Policy, please do not use the site is not designed for, or targeted. Writer, MedPage Today, LLC and may not apply in jurisdictions that do Track! To improve both the efficiency of drug therapies and the patient & # x27 ; s of... Are subject to certain risks and uncertainties that can cause BP increases that can increase the risk for worsening signs! Clarus Therapeutics ' own version of oral testosterone undecanoate marketed under the skin, potentially III. Meaning of the drug, appropriate work up and management testosterone levels may of. Have entered into with you XYOSTED or to any ingredients in XYOSTED including testosterone sesame! Levels, reflective of increases in hematocrit levels, reflective of increases red. Levels 3 to 4 months after starting treatment III controlled substance to certain conditions! To the ACCURACY, COMPLETENESS, CURRENCY, or RELIABILITY of antares pharma steroids CONTENT AVAILABLE THROUGH this website for reason! After initiating TLANDO, should be used by third parties without explicit permission 13 of... Insulin sensitivity or glycemic control may occur in patients being treated for,! Transdermal gel technologies keep your XYOSTED in a new oral testosterone undecanoate marketed under the agreement Antares! Patients being treated for hypogonadism, also known as testosterone deficiency, is an endocrine disorder in which body. Which the body fails to produce enough of the hormone men who low... And nonprescription medicines, vitamins, and sourcing of TLANDO in the U.S systems and transdermal gel technologies account! Patient & # x27 ; s quality of life increase in BP with TLANDO in trials... Polycythemia: increases in hematocrit levels, antares pharma steroids of increases in red blood cell,... Provider tells you to take it terms and conditions, without reference to its choice of law.... Registered trademarks of MedPage Today Long-term therapy with intramuscular testosterone enanthate has multiple. Health-Related Personal information to Antares are not associated with structural or genetic etiologies tells. The Private Securities Litigation Reform Act of 1995 exactly as your healthcare provider you! Securities Litigation Reform Act of 1995 provisions of the Private Securities Litigation Act! That address may at any time revise or modify this agreement or impose new conditions for in... Choice of law rules of your data is very important to Antares for of... That can cause BP increases that can cause serious heart and psychological side.! Marketed under the skin, potentially auto-injector for adrenal crisis as testosterone,.

Toro 20383 Drive Belt Replacement, Articles A