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Natco Pharma Ltd has received tentative approval for Oseltamivir Phosphate capsules from the United States Food & Drug Administration (USFDA).
The Hyderabad-based company has tied up with Alvogen for marketing the product.
"Natco may have first to file approval status for the abbreviated new drug application (ANDA), contingent upon the successful litigation outcome of original drug patent," the company said in a release.
Tamiflu (Roche’s trade name for Oseltamivir Phosphate) had US sales of approximately $495 million for the 12 months ending September 2013, according to IMS Health.
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