Food and Drug Administration
for information regarding data the company has already submitted about Amevive, a psoriasis treatment, but the agency isn't asking for new clinical trials.
Biogen said it has received a "complete response" letter from the FDA requesting some clarification and information related to the data the biotech company has already provided.
The FDA did propose post-marketing clinical studies to further determine the safety and effectiveness of Amevive, and the company said it will work with the agency to address any questions and continue with the approval process.
Last month, an FDA advisory committee voted to recommend Amevive for approval. The FDA doesn't have to follow the recommendations of its panels, but it usually does.
Shares of Biogen rose 25 cents, or 0.6%, to $39.44 in regular trading. After the close, the stock added another 74 cents to $40.18 on the Instinet platform.