Treats spasticity resulting from multiple sclerosis, particularly for the relief of…. NDA 215422, held by Strides Pharma Intl. Baclofen.
As of Nov 13, 2026, NDA 215422 (Lyvispah), held by Strides Pharma Intl, was first approved by FDA on Nov 22, 2021, with 0 approved supplements and 0 published complete response letters.
LYVISPAH is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. LYVISPAH may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use LYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 2021 | Original applicationNew dosage form · Standard review | 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
