Treats spasticity resulting from multiple sclerosis, particularly for the relief of…. NDA 208193, held by Rosemont. Baclofen.
As of Nov 13, 2026, NDA 208193 (Ozobax, Ozobax Ds), held by Rosemont, was first approved by FDA on Sep 18, 2019, with 1 approved supplement and 2 published complete response letters.
Baclofen oral solution 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. Baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use Baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2019 | Original applicationNew dosage form · Standard review | Approved |
| Jun 25, 2018 | Ozobax (baclofen)Product Quality, Nonclinical | Approved |
| Jan 11, 2017 | Ozobax (baclofen)Product Quality, Prea Requirements | Approved |
| Oct 12, 2023 | Supplement 2Manufacturing | Approved | |
| Sep 18, 2019 | 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
