Strides Arcolab Gets FDA Approval For Labetalol Hydrochloride Injection

Labetalol HCl Injection is the generic equivalent of Prometheus Laboratories’ Trandate (Labetalol HCl) Injection. Labetalol HCl 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.

Labetalol HCl Injection is contraindicated in bronchial asthma, overt cardiac failure, greater than first degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product. Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

Ravi Seth, chief executive officer of international operations at Strides, said: “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.”

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.