Aurobindo gets US FDA approval for generic ampicillin

The US Food and Drug Administration (FDA) has approved Aurobindo Pharma Ltd’s application to market generic ampicillin sodium in the US market. The regulator has approved the pharmaceutical company’s application to market the drug in injection form, in six dosage strengths of 10g, 1g, 2g, 125mg, 250mg and 500mg.

Ampicillin is an anti-infective drug based on penicillin, one of the older antibiotics in the market. Anti-infectives are not among the top categories in the US market with lifestyle-related diseases occupying centrestage. It is also a highly generic-driven category, with many players in the market. In addition, penicillin-based antibiotics occupy a smaller share of market, with others like quinolones, cephalosporins being more newer generation of antibiotics.

The company’s share price was up by 7% at the time of posting but the ampicillin approval may not be the reason for that. A fortnight ago it announced its June 2010 quarter results, reporting a 8% increase in consolidated sales to Rs 922 crore but a sharp increase in operating expenses, depreciation and forex-related losses caused its net profit to fall by 69% to Rs 51.5 crore.

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