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Strides Arcolab to launch generic Mesna (Mesnex) injection in US market shortly

Monday, April 19, 2010, 18:47 This news item was posted in Industry category and has 0 Comments so far.

India’s Strides Arcolab has 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.

US FDA has granted marketing approval for its abbreviated new drug application (ANDAs) for  strengths 1 mg per 10ml multi-dose vials, the company said in a press release.

Mesna injection will be available in 1 mg per 10ml multi-dose vials, offered in single packs and in packs of ten.

According to 2009 IMS data, the US market for Mesna approximated US$ 12 million.

Strides is planning to launch Mesna injection shortly in US market.

“This is our second product approval in this month and the fifth for the partnership with Sagent Pharmaceuticals, Inc,” Ravi Seth, CEO – International Operations of Strides, stated in the release.

Mesna is the fifth product being launched under the partnership between Strides and Sagent Pharmaceuticals wherein Strides is developing and supplying more than 25 injectable products for the US market which will be marketed by Sagent.

In February, Strides Arcolab Limited 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.

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

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.

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