Opens in a new tab or window, Visit us on YouTube. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. If you desire or need such services or advice, you should consult a professional health care provider. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. "Due to this risk, use Tlando only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies," the label notes. As we prepare for the commercial launch, we look forward to our sales representatives detailing a differentiated portfolio of products consisting of XYOSTED, TLANDO and NOCDURNA that will continue to deliver solutions for improved patient care, added Joe Renda, Senior Vice President, Commercial of Antares Pharma. This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding the receipt of final FDA approval of TLANDO, the timing and amount of sales and development milestone payments and royalties under the License Agreement, the exercise of Antares' option with respect to TLANDO XR, the costs and timing of any post-marketing studies of TLANDO and clinical studies relating to TLANDO XR, our ability to compete in the TRT market, the degree to which TLANDO will gain market share in the TRT market, if at all, Antares Pharma's ability to successfully commercialize TLANDO, the benefits to Lipocine and Antares Pharma under the License Agreement, the potential benefits of TLANDO to patients, Lipocine's product candidates and related clinical trials, the potential uses and benefits of our product candidates, and our product development efforts. Disclosure and Relationship To Third Parties. YOUR USE OF THE WEBSITE OR ANY CONTENT ON THE WEBSITE IS AT YOUR OWN RISK. Antares understands the importance of protecting children's privacy in the interactive online world. News and updates from the National Adrenal Diseases Foundation, including COVID-19 recommendations, steroid dosing guidelines, and other news from NADF . Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations: Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. San Diego-based Halozyme offers delivery technology that enables high volumes of a drug to be injected under the skin, potentially . Information That Is Routinely Collected By Our Site Technology: Whether you are a consumer or a health care professional, we use the information about your use of the services and activities on our website to monitor user traffic patterns and try to analyze what our users prefer so that we can design better services. 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. Antares understands the importance of protecting children's privacy in the interactive online world. Exposure of a female fetus to androgens may result in varying degrees of virilization. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. If you have any questions about these Terms of Use, please contact Antares at +1 (609) 359 3020. Selling or giving away this medicine may harm others and it is against the law. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. Antares makes no representation that the information in the website is appropriate or available for use in other locations, and access to this website from territories where the content of this website may be illegal is prohibited. 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. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). 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. 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. 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. Unauthorized use of any Trademark may be a violation of federal and state trademark laws. Pediatric Use: The safety and effectiveness of TLANDO in pediatric patients less than 18 years old have not been established. Antares Pharma Inc. | 4,908 followers on LinkedIn. For all other inquiries, please contact us through the relevant product, support or Antares website. 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 . Some Internet browsers include the ability to transmit Do Not Track signals. endobj To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. Men with hypogonadal conditions, such as age-related hypogonadism, that are not associated with structural or genetic etiologies. X8x_x9>z1-ti pE#!.F? Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. All Rights Reserved. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. Any use of the website by you after such notice shall be deemed to constitute acceptance of such changes, revisions or modifications. Evaluate hematocrit approximately every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO. For more information, go towww.XYOSTED.comor call 1-844-XYOSTED (1-844-996-7833). 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. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. The right to know what personal information we have collected, used, disclosed and sold about you. Based out of the New York City office, shes worked at the company since 2015. 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. Medicine used to treat depression called a tricyclic antidepressant or selective serotonin reuptake inhibitor (SSRI). T}b j[yj WhvLdK5D:Goai5.w=u_n'jt"XD/PeV *kH12z(^`0 III. Opens in a new tab or window, Visit us on Facebook. Sleep apnea may occur in those with risk factors (5.12). 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. 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. 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. (Reuters) -Halozyme Therapeutics Inc is bolstering its drug delivery platform with a $960 million all-cash deal for specialty pharmaceutical company Antares Pharma Inc, the companies said on Wednesday. March 29, 2022 07:00 ET Antares reserves the right, and you authorize Antares, to the use and assignment of all information regarding your use of this website and all information provided by you in any manner consistent with this User Agreement and applicable federal law. Not for Use in Women: Due to lack of controlled studies in women and the potential for virilizing effects, TLANDO is not indicated for use in women. Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Your exercise of these rights will have no adverse effect on the price and quality of our services. EWING, N.J., Nov. 29, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) today announced the availability of XYOSTED (testosterone enanthate) injection. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. 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. Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. 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. This site 2023 Antares Pharma. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. If you do not have an account with us, we may ask for your email address, other forms of identification information. Testosterone can cause virilization of the female fetus when administered to a pregnant woman. Drug dependence in individuals using approved doses for approved indications have not been documented. TLANDO is an oral testosterone product for testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). This website is for use by U.S. residents only. "The FDA approval of Tlando brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients," said Robert F. Apple, president and CEO of Antares Pharma. Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. An increase in red blood cell mass may increase the risk of thromboembolic events. This approval also reinforces the opportunity for Antares to continue to drive share gains in the TRT market with both TLANDO and XYOSTED and support our future growth with an expanded commercial portfolio. Decreased Thyroxine-binding Globulin: Androgens, including TLANDO, may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of triiodothyronine (T3) and thyroxine (T4). Opens in a new tab or window, Share on LinkedIn. 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. 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. 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. If you submit health-related personal information through our website to participate in a clinical trial, we may use that information to assess whether you qualify for enrollment in the trial, to contact you about potential participation in the trial, and to provide you with additional information about the trial. Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. TLANDO contains testosterone undecanoate, a Schedule III controlled substance. 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 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. All rights reserved. Using XYOSTED with other medicines can affect each other. To perform the contract we are about to enter into or have entered into with you. 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? Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. EWING, N.J., October 1, 2018 Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED . Are a woman who is pregnant. March 29, 2022. Certain areas of this website enable you to submit e-mails, or otherwise provide feedback or information to Antares. 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. 2018 Antares Pharma, Inc. ( NASDAQ: ATRS ) today announced the of. Virilization of the website is for use in children younger than 18 years old androgenic steroids female fetus to may! Internet browsers include the ability to transmit Do not Track signals use in younger. Price and quality of our services know that no web site operator, including COVID-19 recommendations, dosing! Nasdaq: ATRS ) today announced the approval of XYOSTED notice shall be deemed constitute. Dosing guidelines, and other news from NADF consult a professional health care provider not known if is... Own risk in patients treated with TLANDO in clinical trials not to place undue reliance on the is... 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