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Keeping Track Of CRLs: US FDA Again Faults Bausch + Lomb Manufacturing

 
• By Bridget Silverman

A look at recent developments tracked by the Complete Response Letters chart on the Pink Sheet's US FDA Performance Tracker.

Keeping Track Feature image

Manufacturing continued to be the Achilles heel of ophthalmic drug development as the US FDA issued a second complete response letter (CRL) for Valeant Pharmaceuticals International Inc.'s latanoprostene bunod eye drops citing continued manufacturing deficiencies at the company's Tampa, Fla., facility.

Latanoprostene bunod received its second CRL Aug. 7, less than a month after FDA issued a second CRL to another ophthalmic candidate, Ocular Therapeutix Inc

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