Gland Pharma gets FDA OK for eye allergy drug

• Gland Pharma gets US FDA nod for OTC olopatadine ophthalmic solution 0.7%.
• Generic is equivalent to Alcon's Pataday for allergic conjunctivitis relief.
• Gland Pharma shares rise; strengthens ophthalmic position in US market.

Gland Pharma Limited (Gland), a generic injectable and ophthalmic-focused pharmaceutical company, has received approval from the United States Food and Drug

Administration (FDA) for its abbreviated new drug application (ANDA) filed for olopatadine hydrochloride ophthalmic solution USP, 0.7% (OTC).

The product is therapeutically equivalent to the reference listed drug (RLD), Pataday Once Daily Relief 0.7%, marketed by Alcon Laboratories Inc. It is indicated for the treatment of ocular itching associated with allergic conjunctivitis, offering patients an effective over-the-counter option for relief from allergy-related eye symptoms.

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Gland Pharma has strengthened its position in the ophthalmic segment with this approval, which allows the company to market a therapeutically equivalent product in the highly regulated US market. This milestone underscores Gland’s focus on developing high-quality ophthalmic formulations and expanding its presence in the global pharmaceutical sector.

Following the announcement, Gland Pharma’s shares closed at ₹1,710 on the NSE today, January 7, up ₹16.70 or 0.99%.

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