Lowers the risk of COPD exacerbations. ANDA 208303, held by Zydus Pharms. Roflumilast.
As of Nov 15, 2026, ANDA 208303 (Roflumilast), held by Zydus Pharms, was first approved by FDA on Apr 18, 2023, with 0 approved supplements and 0 published complete response letters.
Roflumilast is a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. ( 1, 14 ) Limitations of Use: Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm. ( 1, 14 ) Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. ( 2, 14 )
| Apr 18, 2023 | Original application | Approved | None posted |
| Feb 10, 2022 | Original application | Approved |
| Roflumilast500MCG · tablet;oral | Roflumilast | Rx |
| Roflumilast250MCG · tablet;oral | Roflumilast | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
