Post by icemandios on Feb 3, 2022 13:56:28 GMT
Antares Pharma Announces FDA Acceptance of NDA Resubmission for TLANDO®
PDUFA target action date set for March 28, 2022
EWING, N.J., Feb. 03, 2022 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the “Company”), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted its New Drug Application (“NDA”) resubmission for TLANDO ® (testosterone undecanoate), an oral treatment for testosterone replacement therapy (“TRT”).
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).
TLANDO ® was granted tentative approval from the FDA as a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. In granting tentative approval, the FDA concluded that TLANDO ® met all required efficacy, quality and safety 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.
“As we take this final step moving from tentative approval to potential final approval in late March, we will continue to prepare for the commercial launch of TLANDO. Our National Sales Meeting is set for the end of April and will serve as the venue to train and ready our sales professionals to start promoting TLANDO to the medical professionals who treat testosterone deficiency. We are excited to be able to complement our current offering of XYOSTED with an oral formulation to patients and physicians. We will leverage our strong physician relationships which we believe will accelerate the adoption of TLANDO, support our future revenue growth and drive our market share gains in the testosterone market,” commented Robert F. Apple, President and Chief Executive Officer of Antares Pharma.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED ® (testosterone enanthate) injection and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA ® (desmopressin acetate) in the U.S. and expects to commercially launch TLANDO ® (testosterone undecanoate) in the U.S. pending final FDA approval.
PDUFA target action date set for March 28, 2022
EWING, N.J., Feb. 03, 2022 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the “Company”), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted its New Drug Application (“NDA”) resubmission for TLANDO ® (testosterone undecanoate), an oral treatment for testosterone replacement therapy (“TRT”).
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).
TLANDO ® was granted tentative approval from the FDA as a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. In granting tentative approval, the FDA concluded that TLANDO ® met all required efficacy, quality and safety 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.
“As we take this final step moving from tentative approval to potential final approval in late March, we will continue to prepare for the commercial launch of TLANDO. Our National Sales Meeting is set for the end of April and will serve as the venue to train and ready our sales professionals to start promoting TLANDO to the medical professionals who treat testosterone deficiency. We are excited to be able to complement our current offering of XYOSTED with an oral formulation to patients and physicians. We will leverage our strong physician relationships which we believe will accelerate the adoption of TLANDO, support our future revenue growth and drive our market share gains in the testosterone market,” commented Robert F. Apple, President and Chief Executive Officer of Antares Pharma.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED ® (testosterone enanthate) injection and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA ® (desmopressin acetate) in the U.S. and expects to commercially launch TLANDO ® (testosterone undecanoate) in the U.S. pending final FDA approval.