Strides Shasun receives US FDA Approval for Cetirizine Softgel Capsules

First Indian generic company to receive approval for Cetirizine (Softgel)

Strides Shasun has received approval from the United States Food & Drug Administration (USFDA) for Cetirizine Hydrochloride Capsules, 10 mg (Liquid Filled Capsules) [OTC].

Cetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/ nose, sneezing, hives, and itching. According to IRI data, the US market for Cetirizine Hydrochloride Capsules (Softgel) is approximately $60 million, with only one other generic player.

The product will be manufactured at the company’s flagship facility at Bangalore and marketed by Strides Pharma Inc in the US Market. The product is ready for launch immediately. The company expects to have an important market share in approximately six months.

This is the first approval for a Softgel product after the recent US FDA inspection at the company’s Bangalore facility.