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Tuesday, January 31, 2023

Zydus gets U.S. FDA nod for two generic drugs

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Zydus Lifesciences on Saturday said it has received approval from the U.S. health regulator to market Silodosin capsules, used in treating benign prostatic hyperplasia, in America.

The company has also received final approval from the U.S. Food and Drug Administration (U.S. FDA) to market Pregabalin capsules in multiple strengths, the Ahmedabad-based drug maker said in a statement.

Silodosin capsules are indicated to treat signs and symptoms of an enlarged prostate gland, 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 treat shingles (herpes zoster) infection. It is also used to treat nerve pain caused by spinal cord injury and pain in people with fibromyalgia.

As per IQVIA data, Silodosin capsules and Pregabalin capsules had annual sales of $14 million and $242 million, respectively in the U.S. market.

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