Zydus receives USFDA approval to market Silodosin and Pregabalin capsules
Drug Approval

Zydus receives USFDA approval to market Silodosin and Pregabalin capsules

Silodosin capsules treat signs and symptoms of an enlarged prostate gland

  • By IPP Bureau | December 12, 2022

Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Silodosin Capsules, 4 mg and 8 mg (USRLD: Rapaflo capsules).

The company has also received the final approval to market Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg (USRLD: Lyrica capsules).

Silodosin capsules treat signs and symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate (benign prostatic hyperplasia or BPH).

Silodosin capsules had annual sales of US $14 million in the United States according to IQVIA data (IQVIA MAT Sep 2022).

Pregabalin capsules are indicated to treat pain caused by nerve damage due to diabetes or to shingles (herpes zoster) infection. It is also used to treat nerve pain caused by spinal cord injury and pain in people with fibromyalgia.

Pregabalin capsules had annual sales of US $242 million in the United States according to IQVIA data (IQVIA MAT Sep 2022).

The group now has 338 approvals and has so far filed over 431 ANDAs since the commencement of the filing process in FY 2003-04.

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