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Amneal Pharmaceuticals Says FDA Approved Abbreviated NDA for Bimatoprost Ophthalmic Generic
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Amneal Pharmaceuticals Says FDA Approved Abbreviated NDA for Bimatoprost Ophthalmic Generic
Sep 23, 2025 6:17 AM

08:47 AM EDT, 09/23/2025 (MT Newswires) -- Amneal Pharmaceuticals ( AMRX ) said Tuesday that the US Food and Drug Administration approved an abbreviated new drug application for bimatoprost ophthalmic solution 0.01%.

The product is a generic equivalent of AbbVie's ( ABBV ) Lumigan, the company said.

Bimatoprost ophthalmic solution is a therapy for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Amneal said.

An abbreviated new drug application is a submission to the FDA for the review and potential approval of a generic version of a drug product.

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