Biologics

FDA approval of BioMimetic’s Augment Bone Graft dependent on more information

In a post-panel response letter, the FDA told BioMimetic Therapeutics Inc. that it would need to submit more information about the safety and efficacy of its Augment Bone Graft in order to receive premarket approval.

According to a press release, the additional information requested by the FDA from the Augment pivotal study includes results relating to antibody safety and reproductive issues, as well as information about post-approval studies to monitor the cancer safety of the product and further evaluate its pharmacokinetic profile in humans.

Augment Bone Graft, which is intended for use as an alternative to autograft in hindfoot and ankle fusion procedures, can potentially be approved for postmarket approval without further clinical trials with the inclusion of this additional information. Accoring to the press release, BioMimetic anticipates that it will be able to submit the necessary information to the FDA by mid-year.

Source: http://www.orthosupersite.com/view.aspx?rid=91239

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Josh Sandberg

Josh Sandberg is the President of Ortho Sales Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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