April 20, 2024

Zydus receives USFDA tentative approval Valbenazine Capsules


NEW DELHI: Zydus Lifesciences today said it has got tentative approval from the US health regulator to market its generic versions of Valbenazine capsules and Roflumilast tablets.

Valbenazine capsules are indicated for the treatment of tardive dyskinesia (uncontrolled movement of body parts such as face and tongue) while Roflumilast tablets are used for reducing risk of chronic obstructive pulmonary disease in severely affected patients associated with chronic bronchitis and a history of exacerbations.

The tentative approval granted by the US Food and Drug Administration (USFDA) to the company’s arm Zydus Worldwide DMCC to market Valbenazine capsules is for strengths 40 mg, 60 mg, and 80 mg, Zydus Lifesciences said in a regulatory filing.

As per IQVIA MAT August 2022 data, Valbenazine capsules had annual sales of USD 781 million in the US. Zydus further said its US subsidiary Zydus Pharmaceuticals (USA) Inc has also received tentative approval from the USFDA to market Roflumilast tablets of strength 250 mcg.

Roflumilast tablets had annual sales of USD 248 million in the US, according to IQVIA MAT August 2022 data, it added. Both the drugs will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ.


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