Zydus Life Gets USFDA Approval for Valbenazine Capsules

9 Aug 2024 , 12:31 PM

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market tardive dyskinesia drug Valbenazine Capsules in 40 mg, 60 mg, and 80 mg strengths.

Valbenazine Capsules, which are prescribed for the treatment of tardive dyskinesia in adults, a condition characterized by uncontrollable movements of the face, tongue, or other body parts, had annual sales of nearly $2 billion in the US in 12 months to June 2024, the company said, citing data from IQVIA

Zydus’ will make the drug at its formulation facility in Ahmedabad, the company said in an exchange release.

This approval grants Zydus 180 days of shared generic drug exclusivity for the 40 mg and 80 mg doses, and 180 days of sole generic drug exclusivity for the 60 mg dose.

Zydus Lifesciences now has 400 USFDA approvals and has filed over 465 ANDAs, it said.

Share of Zydus Lifesciences were trading up 1.4% at ₹1297.60 rupees on stock exchange at 1222 IST.