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NDAs for Valeant’s latanoprostene bunod ophthalmic solution for lowering intraocular pressure and for Ocular Therapeutix’ dexamethasone insert for post-surgical ocular inflammation and pain and allergic conjunctivitis both received complete response letters (CRLs) from FDA due to manufacturing deficiencies uncovered during agency inspections, the two firms announced in late July. Both said the CRLs did not identify efficacy or safety concerns. Valeant reported that the cGMP deficiencies at issue were identified by FDA at a Bausch & Lomb manufacturing facility in Tampa, Florida. Ocular Therapeutix explained in its release that the process and control concerns were identified during a pre-approval inspection, and that the FDA letter “did not provide any details as to which manufacturing deficiencies…remain open since the last response submitted by the company.” The CRLs mean that the applications will not be approved until FDA is satisfied that the GMP issues have been addressed.
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Inside the Global Regulatory Dialogue
