Last Updated on October 11, 2024 by The Health Master
Ahmedabad: Zydus Pharmaceuticals Inc. has received final approval from the USFDA to market Roflumilast Tablets in the strength of 500 mcg.
This comes along with a tentative approval for Roflumilast Tablets in the strength of 250 mcg, generic bioequivalent to Reference Listed Drug 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.
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