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Medicine Summaries
Prescription Drugs

Prescription Drugs
Rejected by the FDA
by Vaughn Aubuchon

This page lists selected prescription drugs that were rejected for approval by the FDA. The drugs are listed by rejection date. The Rejection Date is very useful for searching for additional information about the drug.
.

100

140

.
Rejected
Prescription Drugs Chart

New Drugs that Have Been
Voted Down by the FDA

  Brand Name
  (generic name)

Date
Rejected

  Reason for Rejection

Manufacturer

Condition
Targetted

2014

RLX030
serelaxin

May 16,
2014

insufficient data

Novartis

acute heart failure

Plumiaz
diazepam

May 2,
2014

undisclosed

Acorda Therap.

epilepsy

Moxduo
morphine + oxycodone

Apr. 23,
2014

no advantages
potential for abuse

QRxPharma

pain

Jardiance
empagliflozin

Mar. 5,
2014

manufacturing plant issues

Boehringer Ingelheim

diabetes

2013

Lemtrada
alemtuzumab

Dec. 20,
2013

benefits do not outweigh risks

Genzyme

multiple sclerosis

Girosa
flibanserin

Dec. 11,
2013

risks outweigh benefits

Sprout Pharma.

female libido

(None yet)
suvorexant

Aug. 1,
2013

dose is too strong

Merck

insomnia

Levadex
dihydroergotamine

Apr. 17,
2013

manufacture of canister

Allergan

migrane

2012

Taltorvic
ridaforolimus

Jun. 6,
2012

additional trials required

Merck

sarcoma

Arcalyst
rilonacept

May 8,
2012

inadequate safety data

Regeneron

gout

Loxitane
loxapine

May 5,
2012

severe side effects

Alexza Pharma.

antipsychotic

Orenitram
oral treprostinil

Mar. 25,
2013

lack of supporting data

United Thera.

hypertension

Farxiga
dapagliflozin

Jan. 19,
2012

safety concerns - new trials

Bristol/ Astra.

diabetes

2011

Ilaris
canakinumab

Jun. 21,
2011

long term safety

Novartis

gout

Sollpura
liprotamase

Apr. 18,
2011

another trial required

Lilly

cystic fibrosis

Movectro
cladribine

Mar. 2,
2011

incomplete data, new studies

Merck/ Serono

multiple sclerosis

Contrave
bupropion + naltrexone

Feb. 1,
2011

heart side effects

Orexigen

obesity

2010

Lorqess
lorcaserin

Oct. 24,
2010

Causes cancer in rats
Efficacy highly questioned

Arena Pharma.

obesity

Bydureon
exenatide

Oct. 20,
2010

lack of clinical data

Amylin

diabetes

JZP-6
sodium oxybate

Oct, 12,
2010

the "date-rape" drug
Previously sold as Xyrem in 2002

Jazz Pharma.

fibromyalgia pain killer

Qnexa
phentermine + topiramate

Jul. 16,
2010

Heart rate, birth defects,
psychiatric problems

Vivus, Inc.

obesity

Daxas
roflumilast

May 17,
2010

modest benefit, high risk
suicide and weight loss

Forest Labs

chronic COPD

Naproxcinod
nitronaproxen

May 12,
2010

insufficient data

NicOx

arthritis

Pirespa
pirfenidone

May 4,
2010

additional trials required

Intermune

idiopathic pulmonary fibrosis (IPF)

Acurox
(oxycodone + niacin)

Apr. 22,
2010

side effects, unproven advantage

Acura/ King

painkiller

Afinitor
everolimus

Feb. 9
2010

cost (NHS rejection)

Novartis

kidney cancer

2009

Zeftera
ceftobiprole

Dec. 30
2009

unreliable data

J & J

skin infection

Lyrica
pregabalin

Dec. 25
2009

insufficient evidence to approve
(later approved)

Pfizer

anxiety

Silenor
doxepin

Dec. 7
2009

not effective

Somaxon

insomnia

Lumizyme
alglucosidase alfa

Nov. 16
2009

manufacturing process

Genzyme

Pompe disease

Krystexxa
pegloticase

Aug. 5
2009

manufacturing process

Savient

gout

2008

Remoxy
oxycodone

Dec. 11
2008

further data required

King Pharma.

painkiller

Oritavancin
oritavancin

Dec. 10
2008

not shown to be safe or effective

Targanta

skin infection

Xxxx
iclaprim

Nov. 20
2008

not shown to be safe or effective

Arpida

antibiotic

Cayston
aztreonam lysine

Sept. 17
2008

lack of data

Gilead

cystic fibrosis

Bridion
sugammadex

Aug. 1
2008

concern agout hypersensitivity and allergic reactions

Schering-Plough

anesthesia

Fanapt
iloperidone

July 28
2008

more testing needed

Vanda

schizophrenia

Cipro
ciprofloxacin

July 8
2008

tendonitis and tendon rupture
(new strong warnings required)

Bayer

antibiotic

Cordaptive
MK-0524A

Apr. 26
2008

lack of information
(Tredaptive (in the US)

Merck

cholesterol

Zyprexa
olanzipine

Feb. 28
2008

rejected long-lasting injectable form
"not approvable"

Lilly

schizophrenia

2007

Velexity
gepirone ER

Nov. 3
2007

high risk, bad history

GSK

antidepressant

Arcoxia
etoricoxib

Apr. 27,
2007

additional data required

Merck

arthritis

Frova
frovatriptan succinate

Oct. 2
2007

long-term safety

Vernalis

menstrual migraine

2000

Foscan
temoporfin

Sept. 26,
2000

rejection reason is unclear
meta-tetrahydroxy-phenylchlorin

Scotia Holdings

head and neck cancer

20

140

70

250 - 720

110

130



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Prescrip. Drug Sales

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Prescrip. Drug Side Effects

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Prescrip. Drug TV Ads

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Prescrip. Drug Warnings

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Prescrip. Heart Drugs

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Rejected Prescrip. Drugs

*
Unapproved Prescrip. Drugs




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.

"placed on clinical hold"
"sends warning letter"
"false or misleading"
"promotional material misleading"
"FDA rejected"
"FDA demands more data"
"FDA decision delayed"
"FDA has issues"
"FDA raised safety concerns"
"FDA warns of severe pain"

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Tags: failed drugs, disapproved prescription drugs, FDA drug failures


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This Vaughns FDA-Rejected Prescription
Drugs list was last updated on 2017-06-22.