Glenmark's heart burn treatment drug gets USFDA approval

12 Jun 2024 , 02:13 PM

The United States Food and Drug Administration (USFDA) has given Glenmark Specialty SA (Glenmark) final approval for its Esomeprazole Magnesium delayed-release capsules USP, 20 mg (OTC), which are intended to treat heartburns.

The agency has concluded that the capsules are bioequivalent1 to Haleon U.S. Holdings LLC’s 20 mg OTC Nexium 24 HR delayed-release capsules. Acetazolamide

With the ANDA approval obtained, the medications appear to have a promising future.

The medication is ready to hit the US market and can find a place in the growing market now that it has received the ANDA approval. As on Nielsen syndicated data, the Nexium 24 HR delayed-release capsules, 20 mg (OTC) market3 saw an approximate yearly sales of $259.2 million for the most recent 52-week period ending on May 18, 2024.

Apart from the 197 medications that are now approved for distribution in the US market, Glenmark is a pharmaceutical company with 50 ANDAs awaiting approval from the USFDA.

For feedback and suggestions, write to us at [e-mail]

For opening a demat account click on: https://www.indiainfoline.com/

For doing stock trading & investments, go to: https://ttweb.indiainfoline.com/trade/Login.aspx

For loans, go to: https://www.iifl.com/