Submissions and Approvals

FDA Seeks Industry Input on Improving ANDA Submissions

The FDA is continuing its efforts to improve the ANDA approval process, this time asking generics makers to provide comments on what elements of the process are creating stumbling blocks and how the agency can help clear them away. Read More

FDA OK of Follow-On Osteoarthritis Drug Deepens Nuvo, Mallinckrodt Scrap

The FDA has approved a new formulation of Nuvo Research and Mallinckrodt’s osteoarthritis drug Pennsaid for the treatment of osteoarthritis knee pain, but not the broader indication of signs and symptoms of the disease — adding a new wrinkle to the fight between the two partner companies co-developing the drug. Read More