AcelRx Pharma’s Zalviso approval delayed by FDA
USA-based specialty pharma firm AcelRx Pharmaceuticals (Nasdaq: ACRX) says that the US Food and Drug Administration has issued a Complete Response Letter (CRL) for its New Drug Application for pain management product Zalviso (sufentanil sublingual tablet system).
The company is currently reviewing the FDA's comments and requests contained in the CRL and plans to discuss these requests with the FDA. The CRL contains requests for additional information on the Zalviso System to ensure proper use of the device.
The requests include provision of bench data demonstrating a reduction in the incidence of optical system errors which require premature drug cartridge change, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product.
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