Zydus Lifesciences announced on Monday that it has got tentative approval from the United States Food and Drug Administration (USFDA) to market its generic versions of Valbenazine capsules and Roflumilast tablets.
Valbenazine capsules are indicated for the treatment of tardive dyskinesia. It is a movement disorder that leads to uncontrolled movement of body parts such as the face and tongue.
Meanwhile, Roflumilast tablets are used for reducing the 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 United States. 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.
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According to the company, both drugs will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ.
(With inputs from PTI)
