We improve compliance, absorption, and more with our proprietary drug delivery technology. In addition, Lipocine has granted Antares Pharma an option . TLANDO can cause BP increases that can increase the risk of MACE. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. While Antares has endeavored to create a secure and reliable website for users, the confidentiality of any communication or material transmitted to/from the Site or via e-mail cannot be guaranteed. We are a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Testosterone enanthate auto-injection - Antares Pharma - AdisInsight Drug Profile Testosterone enanthate auto-injection - Antares Pharma Alternative Names: QuickShot testosterone; Testosterone enantate - Antares Pharma; TRT - Antares Pharma; Vibex QS T; Vibex QuickShot T; XYOSTED Latest Information Update: 26 May 2022 Price : $50 * Buy Profile TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Hypercalcemia: Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. 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 drug was also deemed a Schedule III controlled substance, due to risks of abuse and misuse of testosterone. To report side effects to the FDA visitwww.fda.gov/medwatch, or call 1-800-FDA-1088. Known hypersensitivity to testosterone undecanoate or any of TLANDOs ingredients. Get Dragon Pharma Steroids About Antares. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Only some categories of information identify you directly, but each category offers some information about your interests and activities that could be used to make inferences about you. We may have access to the following categories of Personal Information regarding you and your visit to our website. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. 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. These studies did not meet current standards for nonclinical development toxicity studies. If you desire or need such services or advice, you should consult a professional health care provider. None of the information contained herein is intended to be, and shall not be deemed to be, incorporated into any of Antaress securities-related filings or documents. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. Drug dependence in individuals using approved doses for approved indications have not been documented. Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. XYOSTED is the only FDA. "Due to this risk, use Tlando only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies," the label notes. Please note that, while we make reasonable efforts to comply with such requests, deletion of your personal information does not ensure complete and comprehensive removal of that data from all systems. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. combination with other anabolic androgenic steroids. The transaction is expected to be immediately accretive to Halozyme's 2022 revenue and non-GAAP earnings and to accelerate top- and bottom-line growth through 2027, with multiple . Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products . The safety of TLANDO was evaluated in 2 clinical studies in a total of 233 men. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. This website 2023 Halozyme, Inc.All Rights Reserved MPACP--00138. This website may require you to register or obtain a password prior to permitting access to the website or certain services available on this site. 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%. It does not require dose titration. 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. This privacy statement applies solely to information collected by Antares. 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 . March 29, 2022 07:00 ET Antares Pharma's FDA-approved products include XYOSTED (testosterone enanthate) injection, OTREXUP (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. Contact:Tram BuiVice President, Corporate Communications and Investor Relations609-359-3016tbui@antarespharma.com, Primary hypogonadism (congenital or acquired), Hypogonadotropic hypogonadism (congenital or acquired), Safety and efficacy of TLANDO in males less than 18 years old have not been established. 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. 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. Monitor serum calcium concentrations periodically in these patients. Pediatric Use: The safety and effectiveness of TLANDO in pediatric patients less than 18 years old have not been established. You have been unsubscribed from receiving future communications from us. indication and in combination with other anabolic androgenic steroids (5.6). If serum prolactin remains elevated, discontinue TLANDO. Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease (5.10). LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. We also may use a third party verification provider to verify your identity. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. The approval was based on a phase III trial in which about 80% of participants achieved 24-hour average serum testosterone concentrations within the normal range between 300 to 1,080 ng/dL with Tlando, meeting the primary efficacy endpoint. For all other inquiries, please contact us through the relevant product, support or Antares website. Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. Corticosteroids: The concurrent use of testosterone with corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease. Q~wI97S~v # }ZFJ<2gFB\p[ KMSC$U^7D?^Ye^?9CAPG/wv Please see the full Prescribing Information, including Boxed Warning, and Medication Guide. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, The FDA approval of TLANDO brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. TLANDO (testosterone undecanoate) capsules, for oral use, CIII. | Source: 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. Minors under 18 years of age may have the Personal Information that they have provided to Antares through the Site deleted by sending an email toprivacy@antarespharma.comrequesting deletion. The arbitration shall be conducted in the State of Delaware, and judgment on the arbitration award may be entered by any court of competent jurisdiction. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. 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. Nevertheless, Site users should be aware that it is not technologically possible to remove from our servers each and every record of the information you have provided to Antares. We believe TLANDOs oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. All Rights Reserved. Testosterone can cause virilization of the female fetus when administered to a pregnant woman. Antares will not sell your Personal Information or Health-related Personal Information. Your exercise of these rights will have no adverse effect on the price and quality of our services. 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 wish to no longer receive future communications from Antares, please fill in your email address below and click Unsubscribe. For example, do not take XYOSTED if you have low testosterone due to age. Prior to treatment initiation, diagnosis of hypogonadism must be confirmed via morning measurements of serum testosterone concentrations on at least two separate days to see if levels are below the normal range. 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. Know the medicines you take. San Diego-based Halozyme offers delivery technology that enables high volumes of a drug to be injected under the skin, potentially . 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