FDA Approves ANDA209102 for Generic Baclofen Tablets

The U.S. Food and Drug Administration has granted approval for ANDA209102, a generic version of the prescription drug baclofen. The approved application lists baclofen tablets in four strengths—5 mg, 10 mg, 15 mg and 20 mg—intended for oral administration. The products are manufactured by TruPharma LLC, Advagen Pharma Limited, and SOLA Pharmaceuticals, LLC. Approval follows several FDA submissions: a labeling supplement (submission 8) approved on 12 September 2023, a manufacturing (CMC) supplement (submission 15) approved on 5 February 2024, and the original application (submission 1) with an approval letter dated 18 December 2017. The tablets are classified as human prescription drugs and will be marketed under the brand name Baclofen.