Cipla gets USFDA final nod for Esomeprazole ANDA for Oral Suspension

Mumbai: Cipla Limited has announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole for Oral Suspension 10mg, 20mg and 40mg from the United States Food and Drug Administration (US FDA). Cipla is the first company to file for 10mg strength.

Cipla's Esomeprazole for Oral Suspension 10mg, 20mg and 40mg is an AB-rated generic therapeutic equivalent version of AstraZeneca Pharmaceutical's  Nexium®. It is a proton pump inhibitor indicated for the following:

•Treatment of gastroesophageal reflux disease (GERD).

•Risk reduction of NSAID-associated gastric ulcer.

•H. pylori eradication to reduce the risk of duodenal ulcer recurrence.

•Pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

According to IQVIA (IMS Health), Nexium® and its generic equivalents had US sales of approximately $70M for the 12-month period ending November 2019.

The product is available for shipping immediately.

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America, and key regulated and emerging markets.

Its strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective, and CNS segments are well-known.

Its 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Dec'19), 3rd largest in the pharma private market in South Africa, and is among the most dispensed generic players in the U.S.

Its paradigm-changing offer of triple antiretroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility, and affordability to the center of the HIV movement.

A responsible corporate citizen, Cipla's humanitarian approach to healthcare in pursuit of its purpose of 'Caring for Life' and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. 

Read also: Cipla joins hands with CSIR-IICT to develop coronavirus drug