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Drugs in the News

April 29. FDA approves Amitiza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over. FDA News

April 25. FDA updates information to healthcare facilities and healthcare professionals about heparin and heparin-containing medical products. Information

April 25. FDA approves Relistor (methylnaltrexone bromide) for opioid-induced constipation. FDA News

April 22. FDA approves Cimzia (certolizumab pegol) to treat Crohn's disease. FDA News

April 16. FDA issues "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg." Information

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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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