This page lists selected prescription drugs that have NOT BEEN APPROVED by the FDA. The drugs are listed alphabetically.





The FDA estimates that there are THOUSANDS of unapproved drugs being illegally sold in the United States. Doctors write 65 million prescriptions each year for unapproved drugs. The FDA has REFUSED to provide a list of unapproved drugs, in spite of being asked to by the US Congress. That is why I have started compiling the list below.

The previous FDA database has been removed from -
http://www.fda.gov/cder/ndc/index.htm

Vaughn's Summaries

Medical Summaries

Prescription Drug Classes
Prescription Drug Lawsuits
Prescription Drug Painkillers
Prescription Drug Risks
Prescription Drug Sales
Prescription Drug Side Effects

Prescription Drug TV Ads
Prescription Drug Warnings
Prescription Heart Drugs
Rejected Prescription Drugs
Unapproved Prescription Drugs

30

540-860

30

260

  Brand Name
  (generic name)

Notes
Reasons for Being Unapproved

Manufacturer

Condition
Targetted

Amytal
amobarbital

Can cause birth defects - neural tube defect, heart defects, club foot, extra digits, limb deformities, genitourinary malformations, hypospadias, oral cleft

Flynn

anticonvulsant

Andehist

(carbinoxamine maleate, pseudoephedrine hydrochloride)

Cypress

decongestant

Carbofed
carbinoxamine

21 deaths from sedative effects

Hi-Tech

cough and colds

chloral-hydrate

Brand names - Somnote, Aquachloral Supprettes

generic

sedative

colchicine

23 deaths - intravenous back pain
Brand names - Colcrys, Condylon

generic

back pain

Cortane B

(Hydrocortisone/ Pramoxine/ Chloroxylenol)

Blansett

ear drops

E-Ferol

40 babies died

Carter-Glogau

preemie blindness

ergotamine

Brand name - Ergomar
Frequently mixed with caffeine

generic

migraine

Estratest

estrogen-testosterone combination
not proven safe or effective

Solvay

menopause symptoms

estriol

Banned by FDA
not been proven safe or effective
Brand names - Ovestin, Ortho-Gynest

generic

menopause

Hylira

Generic name - Sodium Hyaluronate

Hawthorn

dry skin

ICAR

Dozens of pre-natal vitamin products have disappeared

Cypress

prenatal vitamin

phenobarbitol

Brand names - Luminal, Solfoton

generic

anti-convulsant

quinine

causes irregular heartbeat
Brand names - Qualaquin, Quinerva, Quinite

generic

leg cramps

salsalate

NSAID - Brand names -
Amigesic, Anaflex, Argesic-SA, Disalcid, Marthritic, Mono-Gesic, Salflex, Salsitab

generic

arthritis pain

Synthroid
levothyroxine

Brand names - Levothroid, Levoxyl, Synthroid, Unithroid - Different brands of levothyroxine may not work the same.

Abbott

thyroid

Tindamax
tinidazole

A medicine similar to Tindamax has caused cancer in laboratory animals. It is not known if Tindamax would have the same effect in animals, or in humans.

Mission

bacterial vaginosis

.
The Three Main Categories of Marketed Unapproved Drugs

DESI Drugs
&endash; DESI means Drug Efficacy Study Implementation
&endash; Refers to drugs that were the subject of 1938-1962 NDAs (safety only) and drugs that are identical, related, and similar to such drugs
&endash; DESI drugs are not "grandfathered" or generally recognized as safe and effective (GRAS/E).

Prescription "Wrap-Up" Drugs
&endash; Refers to drugs that are on the market based on a claim of being a pre-'38 or pre-'62 product or identical, related, or similar to such a product.

Post '62 Drugs
&endash; Drugs initially marketed after 1962.

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150

80

260-770

130

130

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