Treats Wilson’s disease, cystinuria. NDA 19854, held by Mylan Speciality LP. Penicillamine.
As of Nov 13, 2026, NDA 19854 (Depen), held by Mylan Speciality LP, was first approved by FDA on Nov 8, 1978, with 5 approved supplements and 0 published complete response letters.
INDICATIONS DEPEN is indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that DEPEN is not of value in ankylosing spondylitis. Wilson’s Disease - Wilson’s disease (hepatolenticular degeneration) results from the interaction of an inherited defect and an abnormality in copper metabolism. The metabolic defect, which is the consequence of the autosomal inheritance of one abnormal gene from each parent, manifests itself in a greater positive copper balance than normal.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 8, 1978 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Depen250MG · tablet;oral | Penicillamine | RxReference drug |
| Aug 17, 1994 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1993 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1990 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 22, 1988 | Supplement 3Labeling | Approved | None posted |
| Nov 10, 1986 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1978 | Original applicationNew formulation or manufacturer · Standard review | 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
