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news.Indian generic drug maker Lupin Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application for Cefdinir capsules 300mg, an AB-rated generic equivalent of Abbott Laboratories' Omnicef capsules for the treatment of bacterial infections.
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According to a source quoted by the company, Omnicef Capsules had US sales of approximately $232 million last year. Cefdinir is an extended-spectrum semisynthetic cephalosporin used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. This is Lupin’s 11th ANDA approval by the FDA to date.
“We are delighted to be granted the first generic approval of Cefdinir capsules and look forward to offering consumers an affordable alternative for this important antibiotic,” commented Vinita Gupta, president and managing director of Lupin Pharmaceuticals.