LIPOCINE ANNOUNCES ITS PARTNER RECEIVED FDA ACCEPTANCE OF NDA RESUBMISSION FOR TLANDO®
Lipocine Inc. (NASDAQ: LPCN) announced that Antares Pharma has received FDA acceptance for the NDA resubmission of TLANDO®, a testosterone replacement therapy. The FDA classified the resubmission as Class 1, with a review period of two months, leading to a target action date of March 28, 2022. TLANDO® is an oral treatment for hypogonadism, previously granted tentative approval by the FDA. This resubmission could enable Lipocine to market TLANDO® in the U.S. after the exclusivity period for JATENZO® expires.
- FDA accepted NDA resubmission for TLANDO® with a target action date of March 28, 2022.
- TLANDO® received tentative approval from the FDA, meeting quality, safety, and efficacy standards.
- The approval is contingent on the expiration of Clarus Therapeutics' exclusivity for JATENZO®, which may impact market entry.
SALT LAKE CITY, Feb. 3, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on developing innovative products for metabolic and endocrine disorders, today announced that Antares Pharma, Inc. issued a press release announcing that the U.S. Food and Drug Administration ("FDA") has accepted its New Drug Application ("NDA") resubmission for TLANDO® (testosterone undecanoate). The FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act (PDUFA). Lipocine licensed the exclusive U.S. rights for TLANDO® to Antares Pharma.
The FDA previously granted tentative approval for TLANDO®, an oral treatment for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. In granting tentative approval, the FDA concluded that TLANDO® met all required quality, safety, and efficacy standards necessary for approval and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. for JATENZO® on March 27, 2022.
About Lipocine
Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO®, TLANDO XR, LPCN 1144, LPCN 1148, LPCN 1107 and oral neurosteroids. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. 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. In a phase 2 clinical evaluation when administered as once or twice daily, TLANDO XR met the typical primary and secondary endpoints. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a Phase 2 clinical study demonstrating potential utility in the treatment of non-cirrhotic NASH. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the management of symptoms associated with liver cirrhosis. 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. For more information, please visit www.lipocine.com.
Forward-Looking Statements
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 Lipocine's product candidates and related clinical trials, the timing of completion of clinical trials, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, and our product development efforts. 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. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.
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SOURCE Lipocine Inc.
FAQ
What did Lipocine announce on February 3, 2022, regarding TLANDO®?
What is the significance of the FDA's Class 1 designation for TLANDO®?
What previous approval did TLANDO® receive from the FDA?
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