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news.Natco Pharma, the India-based partner of Alvogen, has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for the generic version of Tamiflu (oseltamivir phosphate).
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Tamiflu capsules are indicated for the treatment of bird and swine flu infections.
Natco Pharma and Alvogen believe this is the first substantially completed ANDA filing containing a Paragraph IV certification.
They expect to qualify for 180 days of marketing exclusivity upon final approval.
Alvogen Executive Chairman Robert Wessman said the company expects the approved product to offer significant value to its customers and patients.
"The ANDA filing of oseltamivir represents a significant milestone for Alvogen in the US market and complements a fast growing US pipeline of over 70 drugs," Wessman said.