The United States Food and Drug Administration (USFDA) has tentatively approved Zydus Lifesciences' 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. Both medicines would be produced at the group's formulation manufacturing plant in Ahmedabad Special Economic Zone.
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.
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