You are here: Home » Companies » News
Business Standard

Unichem gets USFDA approval for high blood pressure drug Chlorthalidone

Unichem said the product will be commercialised from its Ghaziabad plant

Topics
Unichem Labs | Pharma sector | Pharma industry

Press Trust of India  |  New Delhi 

Unichem Laboratories. Photo: UnichemLabs.com
Unichem Laboratories. Photo: UnichemLabs.com

Drug firm Unichem Laboratories has received approval from the US health regulator to market Chlorthalidone tablets, used to treat high blood pressure.

The company has received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Chlorthalidone tablets USP in the strengths of 25 mg and 50 mg, Unichem Laboratories said in a regulatory filing.

The approved product is a generic version of Hygroton tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC.

Hygroton tablets is indicated in the management of hypertension, either as the sole therapeutic agent or to enhance the effect of other antihypertensive in the more severe forms of hypertension, Unichem Laboratories said.

It is also used as an adjunctive therapy in edema, associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy and the treatment of edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Unichem said the product will be commercialised from its Ghaziabad plant.

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

First Published: Mon, August 12 2019. 10:45 IST
RECOMMENDED FOR YOU
.