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FDA issues Complete Response Letter for TX-004HR, an applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate to severe dyspareunia.- Therapeutics MD Inc.

Read time: 1 mins
Last updated:12th Apr 2017
Published:12th Apr 2017
Source: Pharmawand

Therapeutics MD, Inc. announced that the Company received a letter from the FDA stating that, as part of the FDA�s ongoing review of the Company�s new drug application (NDA) for TX-004HR, the Company�s applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate to severe dyspareunia (vaginal pain during sexual intercourse), a symptom of vulvar and vaginal atrophy (VVA), in post-menopausal women, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. The letter states that the notification does not reflect a final decision on the information under review. The letter does not specify the deficiencies identified by the FDA and at this time the Company is not aware of the nature of the deficiencies. The Company intends to work with the FDA to understand the nature of the deficiencies and resolve them as quickly as possible.

The FDA previously set a target action date under the Prescription Drug User Fee Act (PDUFA) of May 7, 2017 to complete the FDA�s review of the NDA and had communicated to the Company the FDA�s target date of April 9, 2017 for communicating to the Company proposed labeling and/or postmarketing requirements/commitments in accordance with FDA�s PDUFA Reauthorization Performance Goals And Procedures � Fiscal Years 2013 Through 2017.

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