Manages severe spasticity. ANDA 210048, held by Maia Pharms Inc. Baclofen.
As of Nov 13, 2026, ANDA 210048 (Baclofen), held by Maia Pharms Inc, was first approved by FDA on Sep 11, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Baclofen injection (intrathecal) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection (intrathecal) via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 11, 2019 | 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
