>>ISELIN, N.J. (AP) -- Drug company Pharmos Corp. said Monday that its former marketing partner, Bausch & Lomb Inc., received an approvable letter from the Food and Drug Administration for Zylet, a combination anti-inflammatory and antibiotic treatment for eyes.
The FDA issues an approvable letter to tell a company that it will approve a new drug if specific additional information or material is submitted, or specific conditions are met. Bausch & Lomb, who first announced the news in a 10-Q filing on Aug. 3, did not disclose contents of the FDA letter, but said it expects the drug to be approved in the second half of 2004.
In 2001, Bausch & Lomb acquired the rights to Pharmos' loteprednol etabonate ophthalmic business. Bausch & Lomb will pay Pharmos a milestone payment to market Zylet, upon FDA approval. Zylet is aimed at patients with steroid-responsive inflammatory eye conditions who have or are at risk of developing superficial eye infections, Pharmos said.
Shares of Pharmos were down 2 cents, or 0.6 percent, at $3.11 in mid-day trading on the Nasdaq Stock Market. Bausch & Lomb stock was down 1 cent at $60.70 on the New York Stock Exchange.<<
Cheers, Tuck |
