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news.Sagent Pharmaceuticals has received the FDA's approval for azithromycin for injection, a semi-synthetic, macrolide antibiotic that is used to treat a variety of bacterial infections.
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Sagent will offer azithromycin in a 500mg vial for intravenous use. The company anticipates the launch of azithromycin in April 2009.
Under a joint venture agreement, Sagent and Strides Arcolab are developing, supplying and marketing more than 25 injectable products for the US market. Strides is responsible for developing and supplying injectable products that Sagent will market in the US.
Jeffrey Yordon, CEO of Sagent, said: “This approval marks an important milestone for Sagent, as azithromycin is the first product from our joint venture – established in 2007 – with Strides Arcolab. Strides’s manufacturing and development expertise will be invaluable as we move forward with not only azithromycin, one of the world’s most widely used antibiotics, but also with the more than 25 products under development by the joint venture.”