Zydus given FDA OK for generic Daliresp
Zydus Pharmaceuticals has received the Food and Drug Administration’s green light for roflumilast tablets in a dosage strength of 500 mcg.
The company also gained tentative approval from the FDA for the 250 mcg dosage strength of the product.
[Read more: FDA gives tentative nod to Zydus Cadila's generic Truvada]
The medication, which is a generic of Daliresp, is indicated as a treatment to reduce the risk of chronic obstructive pulmonary disease exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
As one of the first applicants for roflumilast tablets, 500 mcg, the company is eligible for 180 days of shared generic drug exclusivity.
[Read More: Zydus Cadila gets FDA OK for generic Robinul]
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.