Drugs
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New generic prevents harmful blood clots
- Treats patients at risk for heart attack, stroke
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FDA approves generic versions of blood thinner Plavix Keep yourself and your family safe in the sun
- Don't Fry Day is May 25
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Sunscreen Rare but deadly infections attack body systems
- Antibacterial agent also reduces risk after exposure
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FDA approves new antibacterial treatment for plague Drug replaces missing enzyme in Type 1 patients
- Expands treatment options for thousands in U.S.
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FDA approves new orphan drug to treat a form of Gaucher disease
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Resources for YouFor Consumers, Health Professionals, Industry
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News and Announcements
FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod) FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies FDA approves new antibacterial treatment for plague
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Program Areas
Advisory Committees - Generic Drugs
Guidances (Drugs) General Information on Manufacturing and Product Quality Regulation of Nonprescription Products Pediatric Product Development Prescription Drug User Fee Act (PDUFA) Small Business Assistance Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
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Approvals & Clearances
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Contact FDA
(888) 463-6332
(301) 796-3400
Human Drug Information
Division of Drug Information (CDER)
Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993
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