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Generics producer granted rights for fluconazole, intends to file antiretroviral.

Vaccine Weekly

| September 01, 2004 | COPYRIGHT 2004 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2004 SEP 1 - (NewsRx.com & NewsRx.net) -- Ranbaxy Laboratories Limited (RLL) announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Fluconazole Tablets and Oral Suspension.

The tablets will be available in 50 mg, 100 mg, 150 mg, and 200 mg strengths and the oral suspension will be offered in 10 mg/mL (50 mg/5mL) and 40 mg/mL (200 mg/5mL). The Office of Generic Drugs, FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Diflucan of Pfizer Central Research. Total market sales for Fluconazole were $741 million (IMS - MAT: ...

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Source: HighBeam Research, Generics producer granted rights for fluconazole, intends to file...

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