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Drugs in the News

• May 1. FDA approves pancrelipase (Creon Delayed-Release Capsules) for adult and pediatric patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), chronic pancreatitis, and other conditions. Drug information

• April 30. FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B). Information

• April 22. FDA updates action on Plan B (levonorgestrel) tablets. FDA Statement

• April 14. FDA imposes restrictions on Coast IRB due to violations. FDA News

• April 14. FDA issues Information for Healthcare Professionals: Ceftriaxone (marketed at Rocephin and generics) Information

• April 8. Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announces that it has begun a voluntary, phased withdrawal of the product from the U.S. market. FDA Statement

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Featured Items

Prescription Drug User Fee Act (PDUFA)
FDA proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would significantly broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public.

National Drug Code Updates
National Drug code information and updating information

Prescription Drug Marketing Act (PDMA)

Drugs Marketed in the United States That Do Not Have Required FDA Approval
FDA has issued a guidance entitled “Marketed Unapproved Drugs--Compliance Policy Guide” designed to make sure that all drugs marketed in the U.S., prescription and over-the-counter, have been shown to be safe and effective.

Facts@FDA Download available Structured Product Labeling file.

Recent Guidances

Structured Product Labeling (SPL) Resources

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current and archival drug labels, drug approval histories, and more