TherapeuticsMD shares tumble after FDA pushes NDA decision to mid ’ 18

TherapeuticsMD (NSDQ:TXMD) shares fell -7% yesterday after the company announced that the FDA accepted its resubmitted application for TX-004HR, an investigational, applicator-free estradiol vaginal soft-gel capsule for the treatment of dyspareunia.
The company’s shares took a hit presumably because it revealed that its resubmitted application is a Class 2 response – a Class 1 response would have quickened the timeline for potential approval. As a Class 2 response, the FDA is slated to make a decision in six months.
Get the full story at our sister site, Drug Delivery Business News.
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Source: Mass Device - December 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Gynecological Pharmaceuticals Regulatory/Compliance Wall Street Beat Women's Health TherapeuticsMD Source Type: news