Lowers the risk of COPD exacerbations. ANDA 208247, held by Strides Pharma. Roflumilast.
As of Nov 15, 2026, ANDA 208247 (Roflumilast), held by Strides Pharma, was first approved by FDA on Mar 30, 2020, 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 tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast 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 |
|---|---|---|---|
| Mar 30, 2020 | Original application | Approved | None posted |
| Roflumilast500MCG · tablet;oral | Roflumilast | Rx |
| Roflumilast250MCG · tablet;oral | Roflumilast | Rx |
| Apr 13, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 30, 2020 | Original application | Approved | None posted |
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
