Gland Pharma Gets USFDA Approval for Olopatadine Ophthalmic Solution

Gland Pharma Ltd said it has received approval from the US Food and Drug Administration for its abbreviated new drug application for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC).

The product is therapeutically equivalent to Pataday Once Daily Relief 0.7%, the reference listed drug of Alcon Laboratories Inc, the company said. It is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

Gland Pharma said the approval strengthens its ophthalmic portfolio in the US over-the-counter market and supports its strategy of expanding its presence in regulated markets.

The company develops, manufactures and markets sterile injectables and ophthalmic products and operates across more than 60 countries under a business-to-business model.