Zydus Life gets USFDA final approvals for Silodosin, Pregabalin

The drug maker announced that it received final approvals from the US drug regulator to market Silodosin and Pregabalin capsules.

The drugs will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad, India.

The approved Silodosin capsules, 4 mg and 8 mg are equivalent to the reference listed drug product (RLD), Rapaflo capsules. It is 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).

Further, Pregabalin capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg is equivalent to the reference listed drug product (RLD), Lyrica capsules. The drug is 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.

According to IQVIA data Silodosin capsules had annual sales of $14 million and Pregabalin capsules had annual sales of $242 million in the United States.

As of 30 September 2022, the Zydus Group had 338 approvals and filed over 431 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is engaged in an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.

On consolidated basis, the company's net profit declined 82.6% to Rs 522.50 crore despite of 7.6% rise in revenue from operations to Rs 3,942.60 crore in Q2 FY23 over Q2 FY22.

Shares of Zydus Lifesciences shed 0.52% to Rs 405.30 on the BSE.

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