Lilly's Cymbalta gets FDA nod for new generalized anxiety disorder indication for maintenance treatment, extending its use beyond the acute treatment setting. 

In a letter to Genzyme detailing findings of a five-week inspection of the Allston Landing, Mass., manufacturing facility, FDA cited 49 observations. One is that despite having developed long-term remedies for the problem of metal particles getting into drugs during the vial-filling process, the company has no short-term plan for dealing with such contamination.

FDA asks Theravance to submit additional data and analyses for its nosocomial pneumonia telavancin application in a Nov. 27 “complete response” letter. Execs do not believe more studies will need to be conducted in response to the letter at this point, however.

Johnson & Johnson's Centocor unit licenses Xencor's Xmab and Xtend antibody drug development technology to develop more potent, longer-lasting antibodies.