Marksans Pharma gets FDA approval for Pregabalin Capsules

Marksans Pharma has secured final approval for its abbreviated new drug application (ANDA) for Pregabalin Capsules from the US Food & Drugs Administration (FDA).

The approval is for the 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg strengths of Pregabalin Capsules. It is indicated in relieving pain resulting from nerve damage because of diabetes, shingles, spinal cord injury, or other conditions.

The drug is a generic of Lyrica Capsules of Upjohn US 2 LLC.

As per IQVIA MAT March 2022, Pregabalin capsules had estimated annual sales of $263 million in the US.