Strides Arcolab Limited has received the US FDA abbreviated new drug approval (ANDA) for Labetalol Hydrochloride (HCl) injection, USP, 100 mg per 20 mL and 200 mg per 40 mL, multi-dose vials. The products are expected to be launched shortly. The product is an outcome of the Strides-Sagent partnership.
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.
According to Ravi Seth, chief executive officer, International Operations, Strides, this ANDA clearance is an addition to the list of approved sterile injectable products for the US market which is another important milestone in the JV partnership with Sagent
This injection Labetalol HCl is the generic equivalent of Prometheus Laboratories’ Trandate (Labetalol HCl) Injection. This 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.
It is contraindicated in bronchial asthma, overt cardiac failure, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension besides 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.
Strides Arcolab, develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.
The company has 14 manufacturing facilities across six countries, including its joint venture with Aspen in India and has a marketing presence in more than 60 countries in developed and emerging markets.
Sagent Pharmaceuticals, founded in 2006, is a privately held specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectable products.