Treats multiple inflammatory nodules with a diameter of 5 mm or greater. ANDA 216633, held by Zydus Pharms. Isotretinoin.
As of Nov 15, 2026, ANDA 216633 (Isotretinoin), held by Zydus Pharms, was first approved by FDA on May 22, 2025, with 4 approved supplements and 0 published complete response letters.
Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use: If a second course of isotretinoin capsules treatment is needed, it is not recommended before a 2 month waiting period because the patient's acne may continue to improve following a 15 week to 20 week course of treatment.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2025 | Original application | Approved | None posted |
| Isotretinoin10MG · capsule;oral | Isotretinoin | Rx |
| Isotretinoin20MG · capsule;oral | Isotretinoin | Rx |
| Isotretinoin25MG · capsule;oral | Isotretinoin | Rx |
| Isotretinoin30MG · capsule;oral | Isotretinoin | Rx |
| Isotretinoin35MG · capsule;oral | Isotretinoin | Rx |
| Isotretinoin40MG · capsule;oral | Isotretinoin | Rx |
| Nov 3, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 3, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Oct 7, 2026 | Supplement 4REMS | Approved | None posted |
| Feb 9, 2026 | Supplement 1REMS | Approved | None posted |
| May 22, 2025 | 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
