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The agency found a lack of evidence that customers used the devices solely for forensic and R&D purposes, as required by their instructions for use. Read More
The approval brings Glenmark’s portfolio to 162 products authorized for distribution in the U.S., with 46 ANDA’s pending approval, the company said. Read More
The premarket approval allows the labeling to state that clinical data showed statistical superiority over autologous bone graft was maintained in its second-year follow-up. Read More