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FDA Grants Final Approval for Glenmark’s Heartburn Capsules

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Glenmark secures FDA final approval for its heartburn capsules, ET HealthWorld

Glenmark Specialty SA (Glenmark) has recently been granted final approval by the United States Food and Drug Administration (USFDA) for its Esomeprazole Magnesium delayed-release capsules USP, 20 mg (OTC), used in the treatment of heartburns. The capsules have been deemed bioequivalent to Nexium 24 HR delayed-release capsules, 20 mg (OTC), by Haleon U.S. Holdings LLC. This approval positions the drug to enter the US market and compete in the growing market for heartburn medications.

According to Nielsen syndicated data for the latest 52-week period ending May 18, 2024, the Nexium 24 HR delayed-release capsules, 20 mg (OTC) market achieved annual sales of approximately $259.2 million. With this approval, Glenmark’s portfolio now includes 197 products authorized for distribution in the US marketplace. Additionally, the company currently has 50 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.

This development marks a significant milestone for Glenmark, as it enhances the company’s presence in the US pharmaceutical market. The approval of Esomeprazole Magnesium delayed-release capsules USP, 20 mg demonstrates the company’s commitment to providing high-quality and effective medications for various health conditions. This news is likely to have a positive impact on Glenmark’s performance and market positioning in the coming months.

Published on Jun 12, 2024 at 12:06 PM IST.

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