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FDA approves Sagent Pharma polymyxin B for injection, USP

The US Food and Drug Administration (FDA) has approved Sagent Pharmaceuticals' polymyxin B for injection, USP for the treatment of infections of urinary tract, meninges and bloodstream caused by susceptible strains of Pseudomonas aeruginosa.

polymyxin B is also intended to be used topically and subconjunctivally to treat eye infection associated by susceptible strains of Pseudomonas aeruginosa.

The product includes PreventIV Measures packaging and labeling which is intended to reduce medication errors.

Under an agreement with Strides Arcolab, both the companies are working together to develop, supply and market more than 20 injectables products for the US market.

The agreement allows Strides to develop and supply injectable products to Sagent for marketing those products in the US.