U.S. Food and Drug Administration • Center for Drug Evaluation and Research

Drug Information

Information about the 
Products We Regulate

• New Prescription Drug Approvals
• Prescription Drug Information
• Drug Information Pathfinder
• Major Drug Information Pages
• Consumer Drug Information
• Over-the-Counter Drug Information
• Drug Safety & Side Effects
• Drug Preparedness and Bioterrorism Response
• Clinical Trials Information
• Public Health Alerts & Warning Letters
• Reports and Publications
• Special Projects & Programs

New Prescription Drug Approvals

• New and Generic Drug Approvals - This is an alphabetical listing of all prescription and over-the-counter drugs approved during 1998 through 2003.   It is updated on a daily basis and contains links to labels, approval letters, and reviews.
• Drugs@FDA
• FDA Drug Approvals List.   This is a reverse chronological listing of all drugs approved from September 1996 to August 12, 2002.
• New Drugs Approved for Cancer Indications. This is a current listing of new cancer drugs.  It is prepared by FDA's Office of Special Health Issues.

Prescription Drug Information

• Approved Drug Products with Therapeutic Equivalence Evaluations/Orange Book. The Orange Book lists all FDA approved prescription drugs, including new and generic drugs.  The Orange Book Page includes a searchable Orange Book, as well as a text version, supplements, and downloadable data files.  It is updated on a monthly basis.
• Biological Therapeutic Products
• Drugs to be Discontinued (Updated 3/20/2002)
• National Drug Code (NDC) Directory (Updated 10/7/2004).  The National Drug Code (NDC) System was originally established as an essential part of an out-of-hospital drug reimbursement program under Medicare. The NDC serves as a universal product identifier for human drugs. The current edition of the National Drug Code Directory is limited to prescription drugs and a few selected OTC products.
• National Drug Code Directory. Searchable Database (10/7/2004) 
• Inactive Ingredient Database.  The database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products. 

Drug Information Pathfinder

• Drug Information Pathfinder. Provides links to information on specific drugs, drug development, drug application process, drug imports, and other topics. (4/22/2004)

Major Drug Information Pages

• Accutane (Isotretinoin) Information Page
• Alimta (pemetrexed for injection) Information Page (2/5/2004)
• Analgesics: Safe Use of Over-the-Counter Pain Relievers (analgesics) and Fever Reducers (antipyretics) (1/22/2004)
• Antidepressant Use in Children, Adolescents, and Adults (3/22/2004)
• Avastin Information Page (2/26/2004)
• Baycol (cerivastatin) Information Page (8/8/2001)
• Cenestin Information: Synthetic Conjugated Estrogens Approved (Updated 3/26/1999)
• Cialis Information Page (11/21/2003)
• Cilostazol (Pletal) Approved (1/15/1999)
• Cipro (Ciprofloxacin Hydrochloride) for Inhalation Anthrax (10/19/2001)
• Doxycycline for Inhalational Anthrax (Post-Exposure) (11/1/2001)
• Calcium-DTPA and Zinc-DTPA (9/12/2003) 
• Eloxatin (oxaliplatin) Information Page (8/12/2002)
• Erbitux Information Page (2/12/2004)
• Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women (1/8/2003, updated 2/10/2004) 
• Exocrine Pancreatic Insufficiency Drug Products (4/27/2004)
• "Fen-Phen" Information (fenfluramine, phentermine, dexfenfluramine) (Updated 7/23/1999)
• Iressa Information Page (5/5/2003)
• Gleevec Information Page
• Lindane Information Page  
• Lotronex Information Page (8/24/2000)
• Mifepristone Information Page (9/28/2000)
• OxyContin Information Page (7/25/2001)
• Palladone (9/24/2004)
• Paxil Information Page (6/19/2003) 
• Penicillin G Procaine for Inhalational Anthrax (Post-Exposure) (11/1/2001)
• Phenylpropanolamine (PPA) Information Page (11/2000, updated 3/17/2003)
• Plenaxis Information Page (11/25/2003)
• Prilosec OTC Information Page (6/20/2003) 
• Prussian Blue Information Page (1/31/2003)  
• Pyridostigmine Bromide  (2/5/2003)  
• Relenza Approved for Flu (8/27/1999) (update 8/21/2000)
• Subutex and Suboxone tablets Information Page (10/8/2002)
• Tamiflu Approved for Flu (8/25/2000)
• Thalidomide Information Page (7/16/1998)
• Unithroid Information Page (8/20/2000)
• Velcade Information Page  
• Viagra Information Page (update 11/24/1998)
• Vioxx Information Page (9/30/2004)
• Xyrem Information Page (7/17/2002)
• Zelnorm Information Page (4/28/2004)

• Antimicrobial Resistance Page (1/25/2001)
• Consumer Drug Information Page -  Basic label information about new, innovator drugs approved by FDA since January 1998.
• Common Drugs of Abuse: Marijuana. Information from the National Institute on Drug Abuse.  
• Consumer Education: What You Should Know About Buying and Using Drug Products
• Beef Insulin: Frequently Asked Questions about Importing Beef Insulin for Personal Use (12/13/2001).
• Drug Shortages
• Generic Drugs: Questions and Answers  
• Influenza Antiviral Drugs and Related Information (12/27/2000).

• Metered-Dose Inhalers (MDIs): Consumer Information (8/9/1999, updated 9/22/2003)

Over-the-Counter Drug Information

• Over-the-Counter Drug Page.  Information for consumers and industry about non-prescription drugs. 

Drug Safety & Side Effects

• Accutane (isotretinoin): A Letter to Consumers and Health Care Providers. Optional Format: PDF.   Dr. Janet Woodcock, CDER Director (1/9/2001)
• Adverse Events Reporting System (Updated 8/7/2002)
• AERS Electronic Submissions (Updated 4/12/2001)
• Clozapine Issue Paper (2/1/2001)
• FDA Medical Bulletin -Important Information for Health Professionals from the U.S. Food and Drug Administration.
• FDA Statement on the Results of the Women's Health Initiative (8/13/2002)
• Labeling Changes Related to Drug Safety.  The summaries include only those safety-related sections that have been modified, and therefore do not contain all the information needed for safe and effective prescribing. Contact the manufacturer for the complete labeling/package insert.
• Labeling Review Branch.   This organization unit page contains recent labeling updates.  
• Medication Errors Web Page
• Medwatch - The web site for the FDA Medical Products Reporting Program.
• Miconazole Vaginal Cream and Suppositories Safety Information (3/5/2001)  FDA updates safety information for Miconazole vaginal cream and suppositories.  FDA advises women who take the prescription blood thinner warfarin to consult their doctor or pharmacist for advice before using over-the-counter miconazole vaginal products.  Using the two products together could cause bleeding or bruising.
• Patient Safety (2/26/2001) Final Summary of Food and Drug Administration (FDA) Action Items - Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact
• Preventable Adverse Drug Reactions:  A Focus on Drug Interactions. (Learning Module).  (6/2002)
• Protease Inhibitors Backgrounder (12/3/1997).  Protease inhibitors are members of a class of antiretrovirals that are generally considered to be the most potent therapeutic agents for HIV to date.  In order for these drugs to be effective and to minimize the risk of resistance, it is important that these drugs are prescribed and taken in accordance with the products' approved labeling.
• Reporting Adverse Reactions and Other Problems with Products Regulated by FDA.  Consumers can play an important public health role by reporting to the U.S. Food and Drug Administration any adverse reactions or other problems with products the agency regulates.
• Safety of Sodium Phosphates Oral Solution (10/12/2001)
• Visicol: Science Backgrounder: Seizure Associated with the Use of Visicol for Colonoscopy - Additional Information (6/27/2002)

Drug Preparedness and Bioterrorism Response

• Drug Preparedness and Bioterrorism Response

Clinical Trials Information

• Information for Clinical Investigators
• Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling:  A Review of New Molecular Entities Approved 1995-1999. (12/7/2001)
• ClinicalTrials.Gov  This source provides patients, families and members of the public easy access to information about the location of clinical trials, their design and purpose, criteria for participation, and, in many cases, further information about the disease and treatment under study.
• Cancer Clinical Trials Listing  (4/6/1999). This is an alphabetical listing of cancer organizations with extensive information about cancer treatments and clinical trials.

Public Health Alerts & Warning Letters

• Alcohol Warnings for Pain Relievers and Fever Reducers (10/22/1998)
• Class Labeling for Intranasal and Orally Inhaled Corticosteroid Containing Drug Products Regarding the Potential for Growth Suppression in Children  (11/9/1998)
• Contamination of Multi-dose Bottles of Albuterol Sulfate Solution for Inhalation (0.5%) - FDA Public Health Advisory. (4/19/2002)
• FDA/CDER Press Notices and Public Health Advisories
• FDA Enforcement Report.   The FDA Enforcement Report is published weekly by the U.S. Food and Drug Administration. It contains information on actions taken in connection with Agency regulatory activities.
• FDA Issues Alert about Misuse of Consumer Products Containing Gamma Hydroxybutyric Acid (GHB), Gamma Butyrolactone (GBL), and 1,4 Butanediol (BD) Letter. and Poster.  Optional Format: GIF. (Posted 7/22/1999)

• FDA Public Health Advisory for Crestor (rosuvastatin) (6/9/2004)

• FDA Response to Letters Requesting Approval of Temozolomide for the Treatment of Adult Patients with Malignant Glioma at First Relapse, April 14, 1999. (Posted 4/23/1999)
• FDA Takes Action against Firm Marketing Unapproved Drugs.  Press release reports injunction sought against marketing of the unapproved drugs: BeneFin, SkinAnswer and MGN-3.  (12/10/1999)
• Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory.  Optional Format: PDF (Issued and Posted 4/5/2001)
• Therapeutic Equivalence of Generic Drugs Letter to Health Practitioners (2/4/1998)
• Therapeutic Equivalence of Generic Drugs Response to National Association of Boards of Pharmacy (2/6/1998)
• Trovan  Health Advisory   (6/9/1999)
• Warning letters and Notice of Violation Letters.  These Warning and Notice of Violation Letters, sorted by month, are supplied by the CDER Freedom of Information Office.

Reports & Publications

• CDER Guide to Median Approval Time Statistics (1/31/2003) 
• Drug Master Files (10/8/2004)
  Drug Master Files (DMFs) are submissions to the FDA containing confidential manufacturing information about drugs, packaging materials, and excipients. This site contains lists of all DMFs through DMF 17678 (DMFs current as of September 30, 2004). The lists are updated quarterly. The site also contains information about filing DMFs.
• Drug Registration and Listing System Instruction Booklet (4/16/1998).  The Drug Listing Act of 1972, amending the Federal Food, Drug, and Cosmetic Act, became effective February 1, 1973. Its purpose is to provide the Commissioner of the FDA  a current list of all drugs manufactured, prepared, propagated, compounded, or processed by a drug establishment registered under the Federal Food, Drug, and Cosmetic Act.
• Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001 (6/18/2002)
• FDA Consumer Special Issue - From Test Tube to Patient.
  This article describes the drug approval process from a consumer perspective.
• FDA's Drug Review and Approval Times (7/27/2001).

Special Projects & Programs

• AIDS Information. Offering the latest federally approved information on research, clinical trials, and treatment for patients and health care providers. (External Site)
• Analgesia and Anti-inflammatory Drug Information (7/15/2002)
• Antiretroviral HIV Drug Approvals and Pediatric Labeling Information (Issued 1/7/1998, Posted 1/7/1998).   This chart lists the drug name, company, adult approval date, and pediatric approval date (if appropriate).
• Botanical Review Team (Botanical Drug Product Development) (3/26/2004)
• Cancer Drug Approval Endpoints: FDA Project and Meeting Information. (11/13/2003)
• FDA Oncology Tools.  Oncology Tools contains a variety of information related to cancer and approved cancer drug therapies
• Pediatric Drug Development
• Pharmaceutical cGMPs: A Risk-Based Approach (2/20/2003)
• Postmarketing Study Commitments (5/2003)

• Process Analytical Technologies (PAT) web page (2/5/2003)

Y2K Prescription Drug Availability

• CDER Year 2000 (Y2K) Information Page (Updated 10/19/1999).

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FDA/Center for Drug Evaluation and Research
Last Updated: September 27, 2004
Originator: OTCOM/DLIS
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