Cipla receives final USFDA approval for Esomeprazole

Mumbai-based drug major, Cipla announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Esomeprazole for oral suspension 10 mg, 20 mg and 40 mg.

Cipla’s Esomeprazole for oral suspension 10 mg, 20 mg and 40 mg is a therapeutic equivalent version of AstraZeneca Pharmaceutical’s Nexium. The drug is a proton pump inhibitor used for the treatment of gastroesophageal reflux disease and for pathological hypersecretory conditions, including Zollinger-Ellison syndrome, among others.

Nexium and its generic equivalents had US sales of approximately US$ 70 million for the 12-month period ending November 2019, according to IQVIA (IMS Health). Cipla is the first company to file for 10 mg strength.

Cipla Limited is a pharmaceutical company offering products for therapeutic areas, including cardiovascular, children's health, dermatology & cosmetology, diabetes, HIV/AIDS, infectious diseases and critical care, malaria, neurosciences, oncology, ophthalmology, osteoporosis, respiratory, urology and women's health. The company manufactures metered dose inhalers, dry powder inhalers, nasal sprays, nebulisers and a range of inhaled accessory devices.

At 2.50 pm on Thursday, the stock was trading at Rs 389.55, up by 3.41 per cent or Rs 12.85 per share. The 52-week high is recorded at Rs 585.50 and the 52-week low is Rs 356.75 on BSE.