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Watson May Bypass Progesterone Gel 8% For Second-Generation Product

Executive Summary

The extent of additional clinical work required pursuant to an FDA “complete response” letter will have to be balanced against the remaining patent life on the product, for which Watson was seeking an indication to prevent preterm birth in women with a short cervix.

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Regulatory News, In Brief

Compounding remains in the news as FDA issues a ‘483 report for the compounding pharmacy behind the fungal meningitis outbreak and as KV Pharmaceuticals tries to block importation of compounded versions of Makena. Other regulatory developments include a settlement over Boehringer’s off-label promotion and a further setback for Watson’s Prochieve.

Watson Hopes Accelerated Approval For Progesterone Gel Remains Option

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.

Watson Pulls Prochieve From Guidance, But Pushes For Approval

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.

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