Gland Pharma, Zydus Lifesciences secure USFDA approvals for key medications

Two major approvals of medications from the US Food and Drug Administration (USFDA) have come today. Gland Pharma and Zydus Lifesciences have received crucial approvals for Latanoprostene Bunod Ophthalmic Solution (eye drops) and Valsartan Tablets (treats hypertension).

Gland Pharma, a Hyderabad-based generic injectable-focused company, received tentative approval for Latanoprostene Bunod Ophthalmic Solution, 0.024 per cent. This eye drop is a bioequivalent and therapeutically equivalent of Bausch & Lomb's Vyzulta Ophthalmic Solution and is used to reduce elevated intraocular pressure in glaucoma and ocular hypertension patients.

The company might be eligible for 180 days of exclusivity upon receiving the final approval, potentially giving them a head start in the Indian market. According to American research organisation IQVIA's data, the branded version of this medication generated approximately $153 million in sales within the last year.

 

Zydus Lifesciences, headquartered in Ahmedabad, received final approval for Valsartan Tablets USP in the following four doses - 40mg, 80mg, 160mg, and 320mg. These tablets are bioequivalent to Diovan tablets and are used for the treatment of hypertension, reducing blood pressure in adults and paediatric patients aged one year and older. They are also used to treat heart failure in adults and improve survival rates after a heart attack.

Zydus will manufacture the tablets at their formulation facility in Ahmedabad, Gujarat. According to IQVIA, Valsartan tablets had annual sales of $149.5 million in the United States as of May 2024. This approval adds to Zydus' portfolio, bringing their total USFDA approvals to 400, with over 460 abbreviated new drug applications (ANDAs) filed since 2003 as of March 31, 2024.

Earlier this month, Zydus Lifesciences received approval from the USFDA for its new drug application for a diabetes medication. The company has received final approval for its new drug application to market Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets.