Topic

FDA

FDA Events

1991 Oct 9 FDA Approves Bristol Myers Squibb's Videx
Treating HIV infection when used in combination with other medicines. Videx Chewable/Dispersible Buffered Tablets are a nucleoside analogue reverse transcriptase inhibitor that stops t...
1991 Oct 31 FDA Approves Bristol Myers Squibb's Pravachol
Pravachol (pravastatin) is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Pravastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and tri...
1991 Nov 7 FDA Approves Sanofi Aventis's Nicoderm CQ
Helping you to quit smoking. Nicoderm CQ Patch is a smoking deterrent. It works by providing low levels of nicotine, which may help you to quit smoking by lessening physical signs of w...
1991 Nov 27 FDA Approves Novartis's Habitrol
Nicotine is the primary ingredient in tobacco products. Nicotine in medical products is used to aid in smoking cessation. Using a controlled amount of nicotine helps reduce nicotine wi...
1992 May 5 FDA Approves Chiron's Proleukin
Treating skin cancer and kidney cancer that has spread to other parts of the body. Proleukin is an antineoplastic. It works by helping enhance many aspects of the immune system, which ...
1992 Jul 31 FDA Approves Pfizer's Norvasc to Lower Hypertension
Norvasc is in a group of drugs called calcium channel blockers. It dilates blood vessels and slows the heart to reduce blood pressure and the pain of angina. Norvasc is used to treat h...
1992 Oct 29 FDA Approves GD Searle's Daypro
Treating rheumatoid arthritis, osteoarthritis, or juvenile arthritis. It may also be used for other conditions as determined by your doctor. Daypro is an NSAID. Exactly how it works is...
1992 Oct 29 FDA Approves Pharmacia and UpJohn's Depo-Provera
Depo-Provera is a form of progesterone, a female hormone that prevents ovulation (the release of an egg from an ovary). Depo-Provera also causes changes in your cervical mucus and uterine...
1992 Dec 16 FDA Approves Sanofi Aventis's Ambien
Ambien is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia). Ambien is used for the short-term treat...
1992 Dec 29 FDA Approves Bristol Myers Squibb's Taxol
Taxol is one of the newer chemotherapy drugs, and has been around, and in use for some years. It is an extract from the bark and needles of the yew tree, Taxus brevifolia. Taxol is a whit...
1992 Dec 29 FDA Approves GlaxoSmithKlein's Paxil
Paxil relieves a variety of emotional problems. It can be prescribed for serious, continuing depression that interferes with your ability to function. Symptoms of this type of depression ...
1993 Mar 29 FDA Approves Sanofi Aventis's Lovenox
Lovenox is an anticoagulant (blood thinner) that prevents the formation of blood clots. Lovenox is used to treat or prevent a type of blood clot called deep vein thrombosis (DVT), whic...
1993 Jul 23 FDA Approves Bayer HealthCare's Betaseron to Treat Relapsing Forms of Multiple Sclearosis
BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and is shown to delay the progression to clinicall...
1993 Aug 23 FDA Approves Meda's Demadex
Demadex, a type of diuretic, is prescribed to treat high blood pressure and water retention. By increasing the amount of water and salt removed from the blood and causing a decrease in bl...
1993 Sep 9 FDA Approves Shionogi Pharma's Cognex
Treating mild to moderate dementia (eg, impairment of memory or judgement, abstract thinking, changes in personality) in patients with Alzheimer disease. Cognex is a cholinesterase inh...
1993 Dec 28 FDA Approves Wyeth Pharm's Effexor
Effexor is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). Effexor works by restoring the balance of certain natural subs...
1993 Dec 29 FDA Approves LEO's Dovonex to Treat Psoriasis
Dovonex (calcipotriene) is a synthetic topical form of vitamin D. It is involved in the growth and development of skin cells. Dovonex is used to treat plaque psoriasis (psoriasis with ...
1994 Jan 11 FDA Approves Bayer's Aleve
Aleve (naproxen) is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Naproxen works by reducing hormones that cause inflammation and pain in the body. Aleve is...
1994 Jun 29 FDA Approves Novartis's Famvir
Famvir is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Famvir will not cure herpes, but it can lessen the symptoms o...
1994 Dec 22 FDA Approves Eisai's Fragmin
Fragmin (dalteparin) is an anticoagulant (blood thinner) that prevents the formation of blood clots. Fragmin is used together with aspirin to prevent blood vessel complications in peop...
1994 Dec 23 FDA Approves Pierre Fabre's Navelbine
NAVELBINE is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced non-small cell lung cancer (NSCLC...
1995 Feb 27 FDA Approves Teva's Toposar
Treating lung cancer and testicular tumors in patients who have not responded to other treatment. It is used in combination with other cancer medications. Toposar is an antineoplastic....
1995 Mar 3 FDA Approves Bristol-Myers Squibb's Glucophage
Glucophage is an oral diabetes medicine that helps control blood sugar levels. Glucophage is for people with type 2 (non-insulin-dependent) diabetes. Glucophage is sometimes used in co...
1995 Mar 3 FDA Approves Novartis's Lotrel to Lower Hypertension
Lotrel is a combination medication that contains an angiotensin converting enzyme (ACE) inhibitor and a calcium-channel blocker. It is used in the treatment of high blood pressure. High b...
1995 Apr 14 FDA Approves Merck's Cozaar to Lower Hypertension
Cozaar is in a group of drugs called angiotensin II receptor antagonists. It keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. Cozaar is used to ...
1995 Apr 28 FDA Approves Merck's Hyzaar to Lower Hypertension
Hyzaar is a combination of losartan and hydrochlorothiazide prescribed to treat patients with high blood pressure. It is in a class of medications called angiotensin II receptor antagonis...
1995 Jun 23 FDA Approves GlaxoSmithKline's Valtrex
Valtrex is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Valtrex will not cure herpes, but it can lessen the symptoms...
1995 Jul 14 FDA Approves Novartis's Neoral
Preventing the rejection of organ transplants (kidney, liver, and heart). Neoral is also used to treat psoriasis and rheumatoid arthritis in certain patients. It may also be used for othe...
1995 Sep 6 FDA Approves Bayer's Precose
Treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines. Precose is a glucosidase inhibitor. It works by slowing do...
1995 Sep 14 FDA Approves GlaxoSmithKlein's Coreg
Coreg is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins). Coreg is used to treat heart failure and hype...
1995 Nov 17 FDA Approves ViiV Healthcare's Epivir
Epivir is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body. The Epivir brand of lamivudine is used to treat HIV, which cause...
1995 Nov 30 FDA Approves Sanofi Aventis's Amaryl
AMARYL (glimepiride tablets) is an oral blood-glucose-lowering drug of the sulfonylurea class. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless pow...
1995 Dec 27 FDA Approves AstraZeneca's Arimidex
Arimidex (chemical name: anastrozole) is an aromatase inhibitor approved by the U.S. Food and Drug Administration (FDA) to treat: post-menopausal women diagnosed with hormone-receptor-...
1996 Mar 1 FDA Approves Abbott's Norvir
Norvir (ritonavir) is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body. Ritonavir prevents human immunodeficiency virus (HIV) c...
1996 May 14 FDA Approves Sanofi Aventis's Taxotere
Drug Type: Taxotere is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Taxotere is classified as a "plant alkaloid," a "taxane" and an "antimicrotubule agent." (F...
1996 May 15 FDA Approves Lilly's Gemzar
Gemzar is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell l...
1996 May 17 FDA Approves Bioniche Pharma's Aloprim
Allopurinol is used to treat chronic gout (gouty arthritis). This condition is caused by too much uric acid in the blood. This medicine works by causing less uric acid to be produced b...
1996 May 17 FDA Approves Bristol Myers Squibb's Etopophos
Treating lung cancer and testicular tumors in patients who have not responded to other treatment. It is used in combination with other cancer medications. Etopophos is an antineoplasti...
1996 Jun 14 FDA Approves Lilly's Humalog
Humalog is an insulin analog that is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog has a more rapid onset and a shorter duration ...
1996 Jun 14 FDA Approves Organon USA's Remeron
Remeron is prescribed for the treatment of major depression—that is, a continuous depressed mood that interferes with everyday life. The symptoms of major depression often include changes...
1996 Jun 14 FDA Approves Pfizer's Camptosar
CAMPTOSAR Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. CAMP...
1996 Aug 23 FDA Approves EMD Serono's Serostim
Increasing lean body weight, body mass, and physical endurance in certain patients with HIV infection. It is usually used along with other medicines that treat HIV infection. It may also ...
1996 Sep 24 FDA Approves Novartis's Denavir
Denavir is a cream containing antiviral medication. Denavir is used topically for the treatment of recurrent cold sores on the lips and face, associated with the herpes simplex virus. ...
1996 Oct 28 FDA Approves Stiefel's Soriatane
Treating severe psoriasis. Soriatane is a kit that contains a vitamin A derivative (retinoid) and moisturizing foam. Exactly how the retinoid works is not known. The moisturizing foam ...
1996 Nov 25 FDA Approves Eisai Inc's Aricept
Aricept improves the function of nerve cells in the brain. It works by preventing the breakdown of a chemical called acetylcholine. People with dementia usually have lower levels of this ...
1996 Dec 17 FDA Approves Pfizer's Lipitor
Lipitor (atorvastatin) is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Atorvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and tri...
1996 Dec 18 FDA Approves Pharmacia and UpJohn's Glyset
Treating type 2 diabetes in adults whose diabetes cannot be managed with diet alone. Glyset may be used alone, in combination with other oral diabetes medicines, or with insulin. Acarb...
1996 Dec 20 FDA Approves Teva's Copaxone to Reduce Frequency in Patients with Relapsing-Remitting Multiple Sclerosis
Copaxone is indicated for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), including patients who have experienced a first clinical e...
1997 Jan FDA Approves Novartis's Diovan to Lower Hypertension
Diovan, in both capsule and tablet formulations, has been approved for the treatment of hypertension in adult subjects. It offers blood pressure control comparable to current leading anti...
1997 May 2 FDA Approves Pharmacia and UpJohn's Nicotrol Inhaler
Helping you to quit smoking. Nicotrol Inhaler is a smoking deterrent. It works by providing low levels of nicotine, which may help you to quit smoking by lessening physical signs of wi...