The Hyderabad-based Natco Pharma has received tentative approval from US Food & Drug Administration (FDA) for its oseltamivir phosphate capsules USP, 30 mg (base), 45 mg (base) and 75 mg (base). Natco has partnered with Alvogen for marketing.
Natco may have first-to-file approval status for the abbrevaited new drug application (ANDA), contingent upon successful litigation outcome of original drug patent. Tamiflu, Roche's trade name for oseltamivir phosphate, had US sales of approximately $ 495 million for twelve months ending September 2013, according to IMS Health.
Natco may have first-to-file approval status for the abbrevaited new drug application (ANDA), contingent upon successful litigation outcome of original drug patent. Tamiflu, Roche's trade name for oseltamivir phosphate, had US sales of approximately $ 495 million for twelve months ending September 2013, according to IMS Health.