Lowers the risk of COPD exacerbations. ANDA 213298, held by Aurobindo Pharma Ltd. Roflumilast.
As of Nov 15, 2026, ANDA 213298 (Roflumilast), held by Aurobindo Pharma Ltd, was first approved by FDA on Apr 17, 2023, with 1 approved supplement and 0 published complete response letters.
Roflumilast tablets are 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 are 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 17, 2023 | Original application | Approved |
| Roflumilast500MCG · tablet;oral | Roflumilast | Rx |
| Roflumilast250MCG · tablet;oral | Roflumilast | Rx |
| Jan 31, 2025 | Supplement 1Manufacturing | Approved | None posted |
| Apr 17, 2023 | Original application | Approved |
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
