New Drug Information, Safety Warnings and Alerts
New Prescription Drug Approvals
- New and Generic Drug Approvals
- This is an alphabetical listing of all prescription drugs approved during 1998 through
2001. It is updated on a daily basis and contains links to labels, approval
letters, and reviews.
- FDA Drug Approvals List.
This is a reverse chronological listing of all drugs approved since September 1996.
It is updated on a weekly basis.
- 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.
- Drugs to be
- National Drug Code (NDC) Directory
(Updated 4/10/2002). 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
- National Drug Code Directory
Searchable Database (4/11/2002)
Major Drug Information Pages
Consumer Drug Information
Over-the-Counter Drug Information
Drug Safety & Side Effects
Clinical Trials Information
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)
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.
- 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.
- 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
- 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
- Drug Master Files (4/24/2002)
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 15913 (DMFs current as of March 30, 2002). Lists are available in
Microsoft Excel and in ASCII format. . In addition, the site contains
information about Type II DMFs and Abbreviated Antibiotic Drug
Applications (AADAs) converted to 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.
- 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 (7/30/2001).
Special Projects & Programs