Zydus Life rises on USFDA nod for two new drug applications

Zydus Lifesciences rose 1.14% to Rs 416.10 after the pharma major said that it had received tentative approval from United States Food and Drug Administration (USFDA) for Valbenazine and Roflumilast tablets.

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).

Valbenazine capsules are a generic equivalent of Ingrezza tablets. According IQVIA, Valbenazine capsules had annual sales of $781million in the US for August 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.

Roflumilast tablets are a generic equivalent of Daliresp tablets. According IQVIA, Roflumilast tablets had estimated annual sales of $248 million in the U.S (August 2022).

Zydus Lifes said that both the drugs will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.

The group now has 326 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company's consolidated net profit fell 11.7% to Rs 518.3 crore on a 1.8% increase in total income from operations to Rs 4,072.7 crore in Q1 FY23 over Q1 FY22.

Powered by Capital Market - Live News