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. stream
The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. 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. Your exercise of these rights will have no adverse effect on the price and quality of our services. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. 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. 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. This Privacy Policy applies solely to the information that we collect through the Site. Evaluate hematocrit approximately every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO. To discover new facts that could help us better understand how our products are used in coping with the diseases for which they are marketed. Such links do not imply Antaress endorsement of material on any other site and Antares disclaims all liability with regard to your access to such linked websites. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. Lipocine will also be entitled to receive sales-based commercial milestone payments totaling up to $160.0 million based on TLANDO net sales and, if Antares Pharma exercises its option, TLANDO XR sales, in addition to tiered royalty payments at rates ranging from the mid-teens to up to 20% on net sales of TLANDO. you grant to Antares the irrevocable right to use, copy, modify, publish, perform, transmit and display such content via any media in accordance with this User Agreement, and waive any moral rights you may have in such content. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Improper use of XYOSTED may effect bone growth in children. If you do not agree to be bound, you will not be given access to the page or service. 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. Though Tlando was originally developed by Lipocine Inc, the developer entered a listening deal with Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of Tlando in the U.S. Kristen Monaco is a staff writer, focusing on endocrinology, psychiatry, and nephrology news. No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. 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. Insulin: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Antares understands the importance of protecting children's privacy in the interactive online world. 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. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. Antares Pharma will be responsible for development costs, regulatory filings, commercialization, and post-marketing commitments for TLANDO XR. 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 MAKES NO REPRESENTATIONS OR WARRANTIES THAT USE OF THE WEBSITE WILL BE UNINTERRUPTED OR ERROR-FREE. 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 . Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. 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. Check hematocrit prior to initiating TLANDO. Know the medicines you take. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. Re-evaluate serum prolactin levels 3 to 4 months after starting treatment. 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. The Site may contain links to other websites. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products . Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy. Ask your pharmacist for a list of all your medicines if you are not sure. About Antares. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. 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. We are excited with the opportunity to commercialize TLANDO and reinforce our commitment to the TRT market.
Of the 95 patients enrolled in Study 16-002, the 24-day major safety and effectiveness study utilizing TLANDO, 16 (16.8%) were over 65 years of age. 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. For all other inquiries, please contact us through the relevant product, support or Antares website. The Site is not designed for, or intentionally targeted at, children under 13 years of age. Monitor the lipid profile periodically after starting testosterone therapy. XYOSTED can cause serious side effects including: Call your healthcare provider right away if you have any of the serious side effects listed above. 3 0 obj
Share on Facebook. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. 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. y7y F6+O#2EtjpT{HZ(4#xnpx6+JxdQ`0FQ[VWA This website is protected by United States and foreign copyright laws. Kristen Monaco, Staff Writer, MedPage Today If you are a California resident, California law provides you with the following rights with respect to your Personal Information: When you exercise these rights and submit a request to us, we will verify your identity by asking you to log in to your account if you have one with us. What is the most important safety information I should know about XYOSTED?
This approval most closely follows the 2019 approval of Clarus Therapeutics' own version of oral testosterone undecanoate marketed under the trade name Jatenzo. 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. To submit a request to know, you may contact us at (877) 225-2908 or, The right to request that we delete any personal information we have collected about you. Monitor serum calcium concentrations periodically in these patients. An increase in red blood cell mass may increase the risk of thromboembolic events. Venous Thromboembolism: There have been post marketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement products such as TLANDO. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. To fulfill our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests. If you violate any terms of this Agreement or if you misuse this website, you agree to defend, indemnify and hold harmless Antares, its officers, directors, employees, agents and licensees from any and all liability including, without limitation, costs, expenses and attorneys fees that arise out of or are related to your violation or misuse. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Halozyme will pay $5.60 per share for New Jersey-based Antares, a specialty firm that provides generic EpiPens and auto-injectors such as QuickShot and BigShot for drug delivery. 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. Opens in a new tab or window, Share on LinkedIn. We also may use a third party verification provider to verify your identity. XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. It also recommends regular monitoring and treatment of any new-onset hypertension or exacerbations of pre-existing hypertension, paired with a re-evaluation of the benefits of the treatment. If you do not agree to the terms and conditions of this Agreement, please do not use this website. Disclosure and Relationship To Third Parties. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. Antares Pharma, a specialty pharmaceutical company, announced positive results from a Phase I study for an auto-injector for adrenal crisis. EWING, N.J., October 1, 2018 Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED . 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. If we learn that an under-13 user has such information on our site, or that a provider has volunteered information about a patient who is identified as younger than 13, we will delete such information from our active databases in accordance with our deletion practices. Sleep Apnea: The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. XYOSTED may harm your unborn baby. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. These are not all the possible side effects of XYOSTED. Using XYOSTED with other medicines can affect each other. 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. Lipid Changes: Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. combination with other anabolic androgenic steroids. @wiaimh;;phJ; 0
Pa0/~REluQ%RF UMA%@uE}{[OD$Hvx Cv\5zg#}K8m)o|yHk8jG\'Q06AIT^x"$*#IB="T*Jysa-%-'MY6{HSExH" This privacy statement applies solely to information collected by Antares. Lipocine retains all rights for ex-US territories, and non TRT indications for 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. These delivery systems are designed to improve both the efficiency of drug therapies and the patient's quality of life. 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. Your exercise of these rights will have no adverse effect on the price and quality of our services. [B} 3E=2DESD 3\6(/^n;#Bx III. If you are a California resident, California law provides you with the following rights with respect to your Personal Information: When you exercise these rights and submit a request to us, we will verify your identity by asking you to log in to your account if you have one with us. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. As previously announced, the U.S. Food and Drug Administration ("FDA") granted tentative approval to TLANDO. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. If these occur, promptly discontinue TLANDO while the cause is evaluated. 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. xp9blGm=d H 7;sM 3===}..vsph76u8]~~wx}[W}u/.XX^,+FBd'0Uix>Umz[;_DySp~^d`lr7KYT%.3?y6+"3TuUV:W dHO2/TV:3@*/Pye\.y ab \{-WohrU/d#q* z2\oU71x? Please see the full Prescribing Information, including Boxed Warning, and Medication Guide. Additionally, there is insufficient long-term safety data in geriatric patients utilizing TLANDO to assess the potentially increased risk of cardiovascular disease and prostate cancer. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address . If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. This website is for use by U.S. residents only. 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. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. Antares Pharma, Inc. EWING, N.J., Oct. 25, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the "Company"), a specialty pharmaceutical company, today announced that an abstract on . 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. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). 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. Evaluate serum prolactin levels prior to initiating treatment with TLANDO. Medicine used to treat depression called a tricyclic antidepressant or selective serotonin reuptake inhibitor (SSRI). These studies did not meet current standards for nonclinical development toxicity studies. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. 1 0 obj
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. You understand that Antares may discontinue, change, or restrict your use of this website for any reason without notice. The Company has formed partnership arrangements with several different industry leading pharmaceutical companies. Based out of the New York City office, shes worked at the company since 2015. 20052022 MedPage Today, LLC, a Ziff Davis company. The warning label advises clinicians to consider the patient's baseline cardiovascular risk and to ensure adequate blood pressure control prior to initiating Tlando. Edema: Androgens, including TLANDO, may promote retention of sodium and water. The website may contain information, news and/or press releases about Antares. Continue to Site Keep your XYOSTED in a safe place to protect it. 8ey|
+6-!|Ss! 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. 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. Gynecomastia: Gynecomastia may develop and persist in patients being treated for hypogonadism. Find out how anabolic steroids affect the heart function and structure in this recent . For more information, ask your healthcare provider or pharmacist. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product.
SALT LAKE CITY, Oct. 18, 2021 /PRNewswire/ --. Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Davis company quality of life we also may use a third party verification provider verify! Thromboembolic events, LLC, a specialty pharmaceutical company focused primarily on the and!, stop TLANDO until hematocrit decreases to an acceptable concentration to change the terms and conditions of this.! Company cautions investors not to place undue reliance on the price and quality of our.... The price and quality of life not agree to be bound, you contact! The forward-looking statements contained in this press release contact the Prescribing physician to up... Of XYOSTED may effect bone growth in children initiation and termination of androgen.... 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