Oprelvekin: "The FDA has approved the drug very recently, in 2006."
Criticism of the Food and Drug Administration: "Some critics believe that the FDA has been too willing to overlook safety concerns in approving new drugs, and is slow to withdraw approved drugs once evidence shows them to be unsafe."
Criticism of the Food and Drug Administration: "Troglitazone and rofecoxib (trade name Vioxx) are high-profile examples of drugs approved by the FDA which were later withdrawn from the market for posing unacceptable risks to patients."
Pramlintide: "Symlin is the only drug approved by the FDA to lower blood sugar in type 1 diabetics since insulin's discovery in the early 1920s."
Omapatrilat: "This drug from BMS was not approved by the FDA due to angioedema safety concerns [Reference: Joshi Venugopal. (2003) Pharmacological modulation of the natriuretic peptide system."
National Drug Code System: "Inclusion of a drug in the directory does not mean that the FDA has approved the drug or that Medicare, Medicaid or other payers will reimburse for it."
Torisel: "Temsirolimus is an intravenous drug for the treatment of renal cell carcinoma (RCC), developed by Wyeth Pharmaceuticals and approved by the FDA in late May 2007."
Monoamine oxidase inhibitor: "Two such drugs, selegiline and rasagiline have been approved by the FDA to not require dietary restrictions, except in high dosage treatment."
Neuropsychopharmacology: "The FDA has approved drugs which selectively act on each of the major neurotransmitters such as NE reuptake inhibitor antidepressants, DA blocker anti-psychotics, and GABA agonist tranquilizers (benzodiazepines)."
Insulin-like growth factor 1: "In August 2005, the FDA approved Tercica's IGF-1 drug, Increlex, as replacement therapy for severe primary IGF-1 deficiency based on clinical trial data from 71 patients."
Lipodissolve: "One of these businesses states on its website that "Pharmacies are permitted to compound drugs pursuant to a valid patient/physician/pharmacist relationship - even if the drugs have not been approved by the FDA.""
Off-label use: "However, once the FDA approves a drug for prescription use, they do not attempt to regulate the practice of medicine, and so the physician makes decisions based on her or his best judgment."
Abortion-related violence: "October 1, 2000: A Catholic priest drove his car into the Northern Illinois Health Clinic after learning that the FDA had approved the drug RU-486."
Eli Lilly Controversy: "The drug instead was approved by the FDA for use in the treatment of adult ADHD, which has become its more common use."
Generic drug: "The FDA must approve generic drugs just as innovator drugs must be approved."
Drotrecogin alfa: "The FDA approved the drug in 2001 as was the case with the drug authorities in many other countries."
Natalizumab: "After an intensive safety evaluation, the drug was re-approved by the FDA as a potentially significant advancement over existing therapies and returned to the marketplace under a program of restricted distribution and regular patient evaluations."