A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Dyax’s DX-2930, an experimental treatment for hereditary angioedema, has won FDA orphan drug designation. The human monoclonal antibody is designed to inhibit plasma kallikrein to reduce swelling, pain and inflammation associated with the disease, the drugmaker says.
Apotex is taking the FDA to court for failing to grant timely approval of its ANDAs for two Sanofi hypertension treatments, Avapro and Avalide. The Office of Generic Drugs (OGD) has yet to approve the ANDAs because the agency’s Office of Compliance cannot locate an inspection report it should have long ago created and reviewed, the Canadian generic-drug maker says. Drug Industry Daily