Spasticity Due to Multiple Sclerosis

• FDA approval · 2025-03-13
  FDA Approved: TIZANIDINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental ANDA for tizanidine from Unichem Pharmaceuticals (USA), Inc., enabling a new generic tizanidine product.

• FDA approval · 2023-11-08
  FDA Approved: BACLOFEN — Original Application (Micro Labs Limited)

  FDA approved an original ANDA for baclofen by Micro Labs Limited, a generic product intended for the management of spasticity.

• CLINICAL_TRIALS trial_result · 2021-05-05
  Clinical Trial Update: BX-1 in Spasticity Due to Multiple Sclerosis [Phase 3]

  Phase 3 clinical trial update for BX-1 in spasticity due to multiple sclerosis has completed.

• FDA approval · 2020-01-13
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's generic tizanidine hydrochloride under an Original Application (ANDA 213223).

• FDA approval · 2019-01-16
  FDA Approved: LIORESAL (BACLOFEN) — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for LIORESAL (baclofen) from Amneal Pharmaceuticals LLC.

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• FDA approval · 2013-11-19
  FDA Approved: LIORESAL (BACLOFEN) — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for LIORESAL (baclofen) from Amneal Pharmaceuticals LLC, updating the product labeling as requested …