OTCQX:MRVFF - Post by User
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PLENRIon Jan 18, 2007 8:53pm
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RE: FDA approvable letter timeline example
RE: FDA approvable letter timeline exampleANOTHER TIMELINE EXAMPLE
Anika Therapeutics Receives FDA Approval for Its Cosmetic Tissue Augmentation Product
WOBURN, Mass., Dec. 21 /PRNewswire-FirstCall/ -- Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it has received FDA approval for its cosmetic tissue augmentation ("CTA") product. CTA is an injectable soft tissue filler for facial wrinkles, scar remediation and lip augmentation. The product is based on Anika's chemically modified hyaluronic acid (HA) proprietary technology and incorporates lidocaine, a local anesthetic. The company had previously announced on November 28, 2006 that it had received an approvable letter for its product.
Anika anticipates filing amendments with the FDA and European Union regulators to enhance product features prior to the launch of the CTA product. Commercialization of this enhanced version of the CTA product is estimated to commence in mid-2007.