Published in Pharma Law Weekly, April 20th, 2004
Penwest plans to submit a 505(b)2 New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by the end of 2004, seeking approval for the higher strengths of the product.
The company intends to complete some additional work to support a manufacturing site change prior to submission. It is currently seeking a marketing partner for this product.
This pivotal study was a randomized, double-blind,...
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