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news.India's Ranbaxy Laboratories has reported developments in both the UK and the US, receiving FDA approval to make and market a generic version of Proctor and Gamble's acute cystitis drug Macrobid in the US, and settling a dispute with the UK Department of Health.
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The FDA’s office of generic drugs has determined the Ranbaxy formulation of nitrofurantoin monohydrate/macrocrystals capsules 100mg to be bioequivalent and have the same therapeutic effect as that of Macrobid.
Nitrofurantoin monohydrate/macrocrystals capsules are indicated for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.
“We are delighted to receive approval from the US FDA to market this product,” said Jim Meehan, vice president of sales and marketing for Ranbaxy Laboratories’ subsidiary Ranbaxy Pharmaceuticals. “Our plans are to bring this product to the market as quickly as possible during the month of April.”
Meanwhile, across the Atlantic, Ranbaxy (UK) Ltd has settled with the UK Department of Health over claims brought against Ranbaxy for alleged anti-competitive cartel conduct in connection with the supply to the NHS of generic drugs between 1996 and 2000.
Under the terms of the settlement Ranbaxy has agreed, without admission of liability, to compensate the NHS by payment of GBP4.5 million and to provide co-operation in the context of the ongoing proceedings.