(Reuters) - Shares of AcelRx Pharmaceuticals Inc plunged nearly 28 percent in premarket trading, after the U.S. Food and Drug Administration rejected its pain drug device, Zalviso, late on Friday. Analysts said they expected the product to eventually receive approval as the issues cited in Zalviso's "rather mild" complete response letter were requests for additional information largely around the device. AcelRx said it would resubmit its marketing application for Zalviso by the end of the year, pending further discussions with the FDA. In its complete response letter to the company, the agency did not ask for any additional efficacy trials but requested additional information to ensure proper use of the device.
via Health News Headlines - Yahoo News http://ift.tt/UFxWmK
via Health News Headlines - Yahoo News http://ift.tt/UFxWmK
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