Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). This product is therapeutically equivalent to Pataday Once Daily Relief, 0.7%, of Alcon Laboratories Inc (Alcon). The ophthalmic solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
USFDA Approval Received
Gland Pharma Limited has secured approval from the United States Food and Drug Administration (USFDA) for its generic injectable and ophthalmic solution. The approval covers its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC), as announced on January 7, 2026.
Product Details
The approved product is therapeutically equivalent to the reference listed drug (RLD), Pataday Once Daily Relief, 0.7%, manufactured by Alcon Laboratories Inc (Alcon). This ophthalmic solution is specifically indicated for alleviating ocular itching related to allergic conjunctivitis.
About Gland Pharma
Established in 1978 in Hyderabad, Gland Pharma has evolved from a contract manufacturer of small-volume liquid parenteral products into a major injectable-focused company. The company operates in 60 countries, including the United States, Europe, Canada, Australia, and India, using a business-to-business (B2B) model. Gland Pharma offers a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
Source: BSE
