Zydus Lifesciences bags tentative USFDA approval to commercialise two drugs; stock gains ~1.5%

17 Oct 2022 , 12:00 PM

The United States Food and Drug Administration (USFDA) has tentatively approved Zydus Lifesciences Limited’s subsidiary Zydus Worldwide DMCC to commercialise Valbenazine Capsules USP 40 mg, 60 mg, and 80 mg. It also received tentative approval to market Roflumilast Tablets USP, 250 mcg.

Valbenazine Capsules are used to treat individuals who have tardive dyskinesia (uncontrollable movements of the face, tongue, or other body parts). Roflumilast Tablets are used to lower the risk of Chronic Obstructive Pulmonary Disease (COPD) exacerbations in patients with severe COPD, chronic bronchitis, and a history of exacerbations.

Both medicines would be produced at the group’s formulation manufacturing plant in Ahmedabad Special Economic Zone, India.

According to IQVIA statistics, Valbenazine Capsules had yearly sales of USD 781 million in the United States, and Roflumilast Tablets had annual sales of USD 248 million.

Since the beginning of the filing procedure in FY 2003-04, the group has received 327 approvals and has submitted over 428 ANDAs.

At around 12.03 PM, Zydus Lifesciences was trading at Rs416.85 up by 1.32% from its previous closing of Rs411.40 on the BSE. The scrip touched intraday high and low of Rs416.90 and Rs409 respectively.

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