Aerie Pharmaceuticals (NSDQ:AERI) said today that Nasdaq has halted trading of the company’s common stock as an FDA committee convenes to review Aerie’s new drug application for its Rhopressa glaucoma and ocular hypertension drug.
The Irvine, Calif.-based company submitted the NDA in February and the FDA is slated to finishing reviewing the application by Feb. 28, 2018.
The NDA under review is a resubmitted application – the initial NDA for Aerie’s Rhopressa eye drops was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection.
In August this year, Aerie said that its contract manufacturer received a complete response letter from the FDA regarding a regulatory application for one of the manufacturer’s own product candidates.
The rejection letter reportedly cites a CGMP inspection at the facility as reasoning for the CRL. The facility also manufactures Aerie’s Rhopressa ophthalmic solution, but Aerie reported that it doesn’t think the manufacturer’s regulatory obstacle will impact the decision deadline for Rhopressa.
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