Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) subsidiary Zydus Worldwide DMCC has received tentative approval from the United States Food and Drug Administration (USFDA) to market Valbenazine Capsules USP 40 mg, 60 mg, and 80 mg (USRLD: Ingrezza®) & Roflumilast Tablets USP, 250 mcg (USRLD: Daliresp®).
Valbenazine Capsules are indicated for the treatment of adults with tardive dyskinesia (movements in the face, tongue, or other body parts that cannot be controlled). The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Valbenazine Capsules had annual sales of USD 781mn in the United States according to IQVIA data (IQVIA MAT Aug 2022).
Roflumilast Tablets are indicated as a treatment to reduce the risk of Chronic Obstructive Pulmonary Disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Roflumilast Tablets had annual sales of USD 248mn in the United States according to IQVIA data (IQVIA MAT Aug 2022).
