Zydus Lifesciences gets FDA final approvals for Silodosin and Pregabalin capsules

Zydus Lifesciences (formerly known as Cadila Healthcare) has secured final approvals from the US Food and Drug Administration (FDA) for Silodosin Capsules, 4 mg and 8 mg and Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg.

The two generic drugs will be manufactured by Zydus Lifesciences at its formulation manufacturing plant in Moraiya, Ahmedabad.

Silodosin Capsules is a generic of Rapaflo capsules, which is approved for the treatment of the signs and symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH).

As per IQVIA MAT Sep 2022, Silodosin capsules had annual sales of $14m in the US.

Zydus Lifesciences gets FDA final approvals for Silodosin and Pregabalin capsules. Photo courtesy of Zydus Cadila.

Pregabalin capsules is a generic of Lyrica capsules, which are approved for the treatment of pain resulting from nerve damage because of diabetes or to shingles (herpes zoster). Besides, it is used for the treatment of nerve pain resulting from spinal cord injury and pain in people having fibromyalgia.

As per IQVIA MAT Sep 2022, Pregabalin capsules had annual sales of $242m in the US.

Zydus Lifesciences has taken its approvals to 338 and to date has filed more than 431 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.