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Once-Daily, Enteric-Coated Videx sNDA Has Oct. 30 User Fee Deadline

Executive Summary

Bristol Myers Squibb has submitted a supplemental NDA for the antiretroviral drug Videx with once-daily dosing. Filed April 30, the application was granted a six-month priority review ending October 30, the company recently announced.

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Bristol-Myers Squibb Videx

Supplemental NDA for once-daily dosing does not include an enteric-coated version (1"The Pink Sheet," Sept. 13, p. 19). Bristol is developing a version of the drug that should eliminate the need for buffers and antacids, the company said

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011




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