Anika close to winning FDA approval for its cosmetic tissue product
A maker of tissue healing products, Anika Therapeutics Inc., reported today that its cosmetic tissue augmentation product is nearing Food and Drug Administration approval.
The Woburn company received an "approvable letter" from the FDA for the product, used as an injectible soft tissue filler for wrinkles, scars, and lip augmentation. Such a letter does not mean the product is approved for use and is normally a request for more data or to further discuss labeling options.
Anika did not say why it received the letter but that final approval was expected by the end of the year.
The company also said it anticipates filing amendments with the FDA and European regulators to enhance the product's features before its planned launched in mid-2007.
Shares of Anika surged $3.07, or 27 percent, to $14.63 on the Nasdaq in midday trading after hitting a 52-week high of $15.37 earlier in the session.
(AP)
