Bangalore, Feb 09, 2010: India-headquartered pharmaceutical company Strides Arcolab has received US FDA approval for its ANDA for Labetalol HCl injection, USP, 100 mg per 20 mL and 200 mg per 40 mL, multi-dose vials. The company is planning to make it available in the market shortly.

Labetalol is the third product launched under the partnership between Strides and Sagent Pharmaceuticals. Under this partnership, Strides and Sagent are jointly developing, supplying and marketing more than 25 injectable products for the US market.

Labetalol HCl injection, the generic equivalent of Prometheus Laboratories’ Trandate injection, is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and non-selective beta-adrenergic receptor blocking actions that is used to control blood pressure in severe hypertension.

Mr Ravi Seth, CEO – International Operations of Strides, siad, “We are pleased to announce this addition to the list of approved sterile injectable products for the US market which is another important milestone in our JV partnership with Sagent.”