Zydus Lifesciences get USFDA nod for 2 generic drugs

On 17 October 2022, Zydus Lifesciences said that the US health agency has given it a preliminary green light to launch its generic versions of Roflumilast pills and Valbenazine capsules. In contrast, Roflumilast tablets are used to lower the risk of chronic obstructive pulmonary disease in severely ill patients who have chronic bronchitis and a history of exacerbations. Valbenazine capsules are indicated for the treatment of tardive dyskinesia (uncontrolled movement of body parts such as the face and tongue).

The US Food and Drug Administration (USFDA) has given the company’s affiliate Zydus Worldwide DMCC a provisional clearance to commercialise Valbenazine capsules in the strengths 40 mg, 60 mg, and 80 mg, according to Zydus Lifesciences in a regulatory filing. Valbenazine capsules had annual sales of USD 781 million in the US, according to IQVIA MAT data from August 2022. Zydus said that the USFDA has given its US subsidiary Zydus Pharmaceuticals (USA) Inc. a provisional permission to commercialise 250 mcg Roflumilast tablets. According to IQVIA MAT data from August 2022, Roflumilast tablets had yearly sales of USD 248 million in the US.The group’s formulation manufacturing plant in Ahmedabad SEZ will produce both medications.

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