FDA-Rejected Prescription Drugs


	Prescription Drugs Rejected by the FDA
	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.		*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

. Disapproved 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
	2010
	Daxas roflumilast	May 17, 2010	modest benefit, high risk suicide and weight loss	Forest Labs	chronic COPD
	Xxx naproxcinod	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
	Frova frovatriptan succinate	Oct. 2 2007	long-term safety	Vernalis	menstrual migraine
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20	150	80	260-770	130	130
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Tags: failed drugs, disapproved prescription drugs, FDA drug failures

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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This Vaughns FDA-Rejected Prescription Drugs list web page was last updated on 2010-05-19.