Relieves flexor spasms and concomitant pain, clonus, and muscular rigidity. ANDA 215885, held by Mankind Pharma. Baclofen.
As of Nov 13, 2026, ANDA 215885 (Baclofen), held by Mankind Pharma, was first approved by FDA on Jan 25, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 2022 | 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
