The FDA has approved a facility in Athlone, Ireland, for production of Rocklatan for the U.S. market, Aerie Pharmaceuticals announced in a press release.
Rocklatan (netarsudil and latanoprost ophthalmic solution 0.02%/0.005%) is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension.
The production plant’s clearance comes after a preapproval inspection of the facility and a review of a new drug application prior approval supplement, which added the facility as a product manufacturing location for the drug.
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