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Discovery Laboratories Inc Receives FDA Recommendations And Request For Clarification Regarding Recently-Submitted SURFAXIN (lucinactant) Updated Product Specifications


Monday, 15 Apr 2013 07:52am EDT 

Discovery Laboratories Inc announced that the U.S. Food and Drug Administration (FDA) has requested clarification and provided recommendations regarding the recently-updated product specifications for SURFAXIN. Discovery Labs plans to provide a response to the FDA within two months. FDA procedure provides up to four months for FDA review of the information provided. If the plan is successful and the FDA agrees with the response, Discovery Labs expects to proceed with the commercial introduction of SURFAXIN in the fourth quarter of 2013. 

Company Quote

1.26
0.01 +0.80%
19 Dec 2014