You are here

FDA Issues Approvable Letter for Orthovisc, Potential Osteoarthritis Treatment

WOBURN, Mass., Dec 2, 2003 (BUSINESS WIRE) -- Anika Therapeutics, Inc. (Nasdaq:ANIK) today said it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for its Pre-Market Approval application (PMA) for ORTHOVISC(R), a highly purified, high molecular weight form of hyaluronic acid for treating patients suffering from osteoarthritis of the knee. The letter states that an approval order will be issued subject to a successful FDA inspection of Anika's manufacturing facility.

"This achievement marks a significant milestone for Anika Therapeutics and we are pleased with the outcome of the FDA's review of our PMA application thus far," said Chief Executive Officer Charles H. Sherwood, Ph.D. "One of our top corporate priorities is to now focus on securing an agreement with a strategic U.S. partner who will lead the commercialization efforts for ORTHOVISC."

Designed to relieve pain and stiffness and improve joint mobility, ORTHOVISC has been marketed internationally since 1996, and currently is sold in Canada and various European and Middle Eastern nations. The U.S. market for viscosupplementation products is growing, with currently over 10 million Americans suffering from osteoarthritis of the knee.

Source: Anika Therapeutics, Inc.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks