Collagen Corp. on Tuesday announced that it has received an"approvable" letter from the FDA for Collagraft Bone GraftMatrix Strip, a second-generation product to treat bonefractures and traumatic osseous defects.
The letter requires Collagen (NASDAQ:CGEN) of Palo Alto, Calif.,to comply with certain conditions before the product can becleared for marketing, the company said.
Collagraft Strip is similar to Collagraft Bone Graft Matrix(Collagraft Implant), which FDA cleared in May, in that both arecomprised of fibrillar collagen, hydroxyapatite and tricalciumphosphate. Unlike Collagraft Implant, however, Collagraft Stripis a premixed, freeze-dried product that will not requirerefrigeration.
Collagraft Strip was jointly developed by Collagen and Bristol-Myers Squibb subsidiary Zimmer Inc., which holds U.S. andAsian marketing rights to the product.
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