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.
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