Zydus Lifesciences bags USFDA nod for Silodosin, Pregabalin capsules

Ahmedabad: 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 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). Silodosin capsules had annual sales of USD 14 mn 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 USD 242 mn 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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Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.

Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide

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