Aerie Reports FDA Concerns over Contract Manufacturer’s Plant

August 11, 2017: By Jon Swedien

1 Ophthalmic NewsThe US FDA recently flagged manufacturing problems at the Tampa, Florida, plant that Aerie Pharmaceuticals uses as a contract manufacturer for Rhopressa, the Irvine, California, company announced Aug. 8.

Aerie said, “We currently believe it is probable that open issues will be resolved prior to the Feb. 28, 2018, target action date for Rhopressa.”

Aerie said it was given notice from the contract manufacturer that it received a complete response letter (CRL) from the FDA regarding a new drug application (NDA) for one of its own product candidates made at its Tampa facility.

Aerie did not name the contract manufacturer, though Valeant Pharmaceuticals announced on Aug. 7 that it received a CRL from the FDA in response to subsidiary Bausch + Lomb’s NDA for Vyzulta after the agency flagged issues at B+L’s manufacturing facility in Tampa.

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