Drug major Cipla on Thursday said it has received final approval from the US health regulator for generic Esomeprazole for oral suspension used for treatment of gastroesophageal reflux disease.
The company has received final approval for its abbreviated new drug application (ANDA) for Esomeprazole for oral suspension in the strengths of 10mg, 20mg and 40mg from the United States Food and Drug Administration (USFDA), Cipla said in a statement.
Cipla is the first company to file for the 10mg strength, it added. The product is a generic version ofAstraZeneca Pharmaceutical's Nexium.It is indicated for thetreatment of gastroesophageal reflux disease, risk reduction of NSAID-associated gastric ulcer, among others, Cipla said.
According to IQVIA, Nexium and its generic equivalents had US sales of around USD 70 million for the 12 months ended November 2019, it added.
Shares of Cipla were trading at Rs389per scrip on the BSE,up 3.27 per cent from the previous close.
(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.