You are here

Generic Floxin Otic Solution Granted Tentative Approval

AMITYVILLE, N.Y.--(BUSINESS WIRE)--May 11, 2005--Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK - News) announced today that the US Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for Ofloxacin otic solution, 0.3%. Hi-Tech's Ofloxacin otic solution is the generic equivalent of Daiichi's Floxin otic solution, 0.3% indicated for the treatment of bacterial infections of the ear which in 2004, had sales of $77 million.

Floxin is covered by a US patent listed in the Orange Book and currently subject to a litigation between Daiichi and Bausch & Lomb, which was first to file an ANDA on this product. If the U.S. patent listed in the Orange Book is held invalid or unenforceable, Bausch & Lomb will be granted marketing exclusivity for 180 days. Hi-Tech expects to start marketing its generic version of Floxin upon expiration of this marketing exclusivity period, or upon expiration of the patent in 2012.

Source: Hi-Tech Pharmacal

Recent Headlines

A new 'road map' might make it easier
Rationing, canceled treatments, and fearful patients
Your heart will thank you
Seems like the 2013 Guidelines are having an impact
Biomarker blood tests pick up subtle clues
Meeting 'zombie cells' along the way
Drug resistance in HIV patients has nearly tripled since 2001
New drug addresses bacterial resistance to standard therapy