FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) To Full Approval For Use In Cutaneous T-Cell Lymphoma ... (Medical News Today)
Eisai Corporation of North America announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics license application (sBLA) for ONTAK(R). The sBLA seeks to convert an accelerated approval indication into full approval.

FDA approves Akorn-Strides's two ANDAs for Famotidine Injection (Pharmaceutical Business Review)
Akorn-Strides has announced the approvals of two abbreviated new drug applications for Famotidine Injection USP, 20 mg/2mL single-dose vials and 40 mg/4mL and 200 mg/20mL multiple-dose vials.

Exciting Developments At The FDA - Annual Meeting Of The American Urological Association (Medical News Today)
ORLANDO, FL (UroToday.com) - Dr. Andrew von Eschenbach discussed developments at the FDA. He addressed the FDA mission to protect and promote public health. The FDA has been in existence since 1906. The FDA regulates 20% of everything we consume to include most food, drugs, medical devices, animal feed and drugs, cosmetics and radiation devices. The budget for this is modest at 2.