Zydus receives tentative approval from the USFDA for Roflumilast Tablets

Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Roflumilast Tablets USP, 250 mcg (USRLD: Daliresp®).

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).

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.

Shares of Cadila Healthcare Limited was last trading in BSE at Rs. 411.40 as compared to the previous close of Rs. 414.15. The total number of shares traded during the day was 26916 in over 982 trades.

The stock hit an intraday high of Rs. 420.00 and intraday low of 410.30. The net turnover during the day was Rs. 11155410.00.

(*as of 30th June 2022)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 ZydusPharmaceuticalsUSAInc TentativeApproval RoflumilastTablets