Strides Arcolab’s vecuronium bromide injection gets approval in US

India’s Strides Arcolab Limited received marketing approval for vecuronium bromide injection US Food and Drug Administration.

Vecuronium bromide injection is a neuromuscular blocking agent of intermediate duration. It  is used as an adjunct to general anesthaesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Vecuronium is available in 10mg and 20 mg per vial.

Vecuronium will be offered as 10mg and 20 mg, AP-rated, sterile nonpyrogenic freeze-dried product in packages of ten.

The total 2009 US market for injectable vecuronium is estimated at around US$ 10 million, according to IMS data.

Strides is gearing up to launch vecuronium bromide injection in the next few months.

Vecuronium bromide injection will be developed under the partnership between Strides and Akorn Inc.

Strides is developing and supplying 22 injectable products for the US market which will be marketed by Akorn Inc for Akorn-Strides, LLC, a joint venture between Strides and Akorn Inc.

This week, Strides Acrolab has also received US FDA approval for marketing and distributing bacitracin injections in US.

Bacitracin is an anti-infective used to treat pneumonia and empyema.

In April, Strides Arcolab has received US FDA approval for its Abbreviated New Drug Application (ANDA) to market metoprolol tartrate injection, USP.

The drug is the generic equivalent of Novartis Pharmaceutical Corporation’s Lopressor (metoprolol tartrate injection, USP).

Strides Arcolab has also received US FDA approval for its generic Mensa injection.

Mesna is the therapeutic equivalent of Baxter International’s Mesnex. Mesna is a prophylactic agent used to reduce the incidence of haemorrhagic cystitis caused by ifosfamide or cyclophosphamide  chemotherapy.

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.

In January, Strides Arcolab entered into a collaboration with Pfizer on the supply of 40 generic products.

Under the new collaboration Pfizer will commercialize Stride’s off-patent sterile injectable and oral products in the United States through its Established Products Business Unit.

These finished dosage form products will be licensed and supplied by Strides and Onco Laboratories Limited and Onco Therapies Limited, two joint ventures between Strides and Aspen, South Africa, in which each has a 50% ownership interest.

The first of the products commercialized under Pfizer-Strides collaboration is expected to be launched in 2010.

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.

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.