FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Valeant Says FDA Likes Progress on B + L Fixes

Aug. 30, 2017
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New and current applications for FDA drug approvals by Canada’sValeant Pharmaceuticals won’t be clouded by recent inspections that identified problems at the company’s Bausch + Lomb manufacturing plant in Tampa, Valeant said.

Valeant said the agency confirmed it is satisfied with the company’s steps to fix the problems, and the plant will receive a voluntary action indicated inspection classification.

Valeant has twice failed to gain FDA approval for a new formulation of eye drops to treat glaucoma because of lingering problems at the Bausch + Lomb plant.

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