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Strides Arcolab wins US FDA approval for generic labetalol (Trandate) injection to treat blood pressure

Tuesday, February 9, 2010, 19:30 This news item was posted in Industry category and has 0 Comments so far.

Strides Arcolab Limited has received marketing approval for generic labetalol injection to treat hypertension in US.

US FDA has granted approval for Stride’s 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 company announced in a press release.

Strides generic labetalol is the therapeutic equivalent of Prometheus Laboratories’ Trandate  injection.

Labetalol 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.

Strides plans to launch labetalol injection shortly in the US market.

Labetalol is the third product to be 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.

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.

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