Aurobindo Pharma gets USFDA approval for drug used to sedate patients

Representative photo of a vaccine

Drug major Aurobindo Pharma On Wednesday said it has received final approval from the US health regulator for generic of Precedex injection, used for sedation of patients.

The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.9 per cent sodium chloride injection, 200 g/50 mL and 400 g/100 mL single dose flexible containers (bags), Aurobindo Pharma said in a regulatory filing.

Aurobindo said the approved product is a therapeutic equivalent generic version of Hospira's Precedex in 0.9 per cent sodium chloride injection.

The company said the product will be launched in January 2021.

Dexmedetomidine Hydrochloride in 0.9 per cent sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures.

Quoting IQVIA data, Aurobindo Pharma said the approved product has an estimated market size of USD 228 million for the 12 months ending October 2020.

Aurobindo now has a total of 459 abbreviated new drug application (ANDA) approvals (431 final and 28 tentative) from USFDA.

Shares of Aurobindo Pharma were trading 0.95 per cent higher at Rs 904.30 apiece on BSE.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

Dear Reader,

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.

Digital Editor

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel