Zydus Lifesciences gets two approvals from USFDA for Silodosin capsules, Pregabalin capsules

10 Dec 2022 Evaluate

Zydus Lifesciences 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 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 are indicated to treat signs and symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate (benign prostatic hyperplasia or BPH).

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.

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.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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