Glenmark Pharma gets USFDA approval for Esomeprazole capsules

Glenmark Pharmaceuticals Inc., USA, has been granted final approval by the USFDA for Esomeprazole magnesium delayed-release capsules USP, 20 mg and 40 mg, a generic version of Nexium delayed‐release capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP.  

Esomeprazole is used for treating stomach and esophagus problems like acid reflux, ulcers, etc. As per the IQVIA sales data for the 12-month period ending March 2019, the Nexium delayed‐release capsules, 20 mg and 40 mg market achieved annual sales of USD 395.1 million.

Last week, the company had announced positive results from Phase 3 study of Ryaltris, an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) to be used in patients aged 6 to 12. Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), also known as GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name.

Glenmark’s current portfolio consists of 153 products authorised for distribution in the US marketplace, while 58 ANDAs are pending approval with the USFDA.

On Monday, the stock of Glenmark Pharma had closed at Rs 591.65. On Tuesday, it opened at Rs 581.10 and surged by 2.9 per cent to Rs 608.90.