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Appeals
06-30-2008 |  12:38 hs.

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Surfaxin for respiratory distress syndrome
05-05-2008 |  10:29 hs.
Discovery Laboratories Inc reported it may be able to respond to U.S. regulatory concerns about its experimental infant lung drug in six to eight weeks, and could win another review for the product within 60 days. Last week, the small biotech company received an “approvable letter” from the Food and Drug Administration (FDA) for Surfaxin, which means the company must satisfy further conditions before the FDA will approve the drug. Shares in the company had dropped to half. Further details.

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NDA for Once-Daily Pain Formula
04-02-2008 |  09:30 hs.
Labopharm Inc announced it planned to further its appeal on the U.S. Food and Drug Administration's (FDA) ruling of its once-daily pain formula tramadol. In May 2007, the company had received a letter of non-approval from the FDA, noting certain conditions must be met. Further details.

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