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Medicine Summaries
Prescription Drugs

Prescription Drugs
UNAPPROVED by the FDA

by Vaughn Aubuchon

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

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100

60

30

80

80

30

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Unapproved Prescription Drugs Chart
Drugs that Have NOT BEEN APPROVED by the FDA

  Brand Name
  (generic name)

Date

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

2006

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

1980's

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

2001

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

Prescription "Wrap-Up" Drugs
--- 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
--- Drugs initially marketed after 1962.

100

60

260 - 660

110

130


Disclaimer
The author is not a doctor.
NO MEDICAL ADVICE IS OFFERED OR IMPLIED.
Statements on this page may NOT be correct.

These are just my personal thoughts.
The sole purpose of this page is to encourage further research on your part.

I hope that you have found this prescription drug lawsuit page helpful.
Thank you very much for your time.

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Tags: FDA unapproved drugs, unapproved prescription drugs


Vaughn's Summaries
©2010   Vaughn Aubuchon
www.vaughns-1-pagers.com
All Rights Reserved.
This Vaughns FDA-Unapproved Prescription Drugs list
was last updated on 2013-11-11.