Lowers the risk of COPD exacerbations. ANDA 212490, held by Alkem Labs Ltd. Roflumilast.
As of Nov 15, 2026, ANDA 212490 (Roflumilast), held by Alkem Labs Ltd, was first approved by FDA on Apr 18, 2023, with 0 approved supplements and 0 published complete response letters.
Roflumilast tablets is 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. Limitations of Use Roflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 18, 2023 | Original application | Approved |
| Roflumilast250MCG · tablet;oral | Roflumilast | Rx |
| Roflumilast500MCG · 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
