Zydus gets 180 days shared exclusivity for Roflumilast Tablets

Zydus' U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the USFDA to market Roflumilast Tablets in the strength of 500 mcg and a tentative approval for Roflumilast Tablets, 250 mcg (US RLD - DALIRESP®). Zydus being one of the first applicants for Roflumilast Tablets, 500 mcg is eligible for 180 days of shared generic drug exclusivity under section 505(j)(5)(B)(iv) of the FD&C Act. Zydus' 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 the SEZ, Ahmedabad.

The group now has 327 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Cadila Healthcare Limited was last trading in BSE at Rs. 382.85 as compared to the previous close of Rs. 392.20. The total number of shares traded during the day was 84130 in over 2766 trades.

The stock hit an intraday high of Rs. 392.25 and intraday low of 380.00. The net turnover during the day was Rs. 32519915.00.

Source : Equity Bulls

Keywords

CadilaHealthcare INE010B01027 USFDA Approval RoflumilastTablets