FDA hands Biovail a non-approval letter

The FDA has slapped Canada-based Biovail with a Non-Approval letter for BVF-033, a once-daily salt formulation of bupropion. The FDA said the design of the pharmacokinetic studies required to support the NDA was not sufficient. The company said that though it believes the studies were adequate, it will meet with the agency to resolve the problem.

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PLUS: Funding remains crucial for Canada's biotech industry. Release

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