Watson Hopes Accelerated Approval For Progesterone Gel Remains Option
This article was originally published in Pharmaceutical Approvals Monthly
Company will meet with FDA to determine a path forward now that the agency has issued a “complete response” letter for progesterone vaginal gel 8% for reducing the risk of preterm birth in women with a short cervix, Watson CEO Bisaro says.
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Despite a disappointing advisory committee review for its progesterone gel for preterm birth, Watson said it will continue to push for approval. The company also bolsters its Australian generics business with the acquisition of Ascent.
The agency rejects the sponsor’s statistical analysis and says there is no statistically significant evidence of efficacy in the U.S. population, and the product seems likely to face a request for another trial from the advisory panel.
Approval of the pre-term birth prevention therapy could pull KV Pharmaceutical back from the brink.