FDA Events

1946 Mar 4 FDA Approves Parke-Davis's Benadryl
Benadryl is an antihistamine. Diphenhydramine blocks the effects of the naturally occurring chemical histamine in the body. Benadryl is used to treat sneezing; runny nose; itching, wat...
1953 Dec 7 FDA Approves Dava's Methotrexate
Methotrexate interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells. Methotrexate is ...
1955 Apr 18 FDA Approves Sanodi Aventis's Plaquenil
Plaquenil is considered an older disease-modifying anti-rheumatic drug or DMARD. Plaquenil is actually in a class of medications called anti-malarials but it is also used to treat rheumat...
1956 Apr 12 FDA Approves Pfizer's Atarax
Atarax is an antihistamine used to relieve the symptoms of common anxiety and tension and, in combination with other medications, to treat anxiety that results from physical illness. It a...
1959 Mar 9 FDA Approves Immunex's Thiotepa
Why would this drug be used? Thiotepa is used to treat lymphoma and cancers of the breast, ovary, bladder, and other cancer types. It may also be used to control the fluid that can b...
1959 May 18 FDA Approves Pharmacia and UpJohn's Solu-Medrol Solution
Treating certain conditions associated with decreased adrenal gland function. It is also used to treat severe inflammation caused by certain conditions, including severe asthma, severe al...
1960 Jan 21 FDA Approves GD Searle's Aldactone
Aldactone is a potassium-sparing diuretic (water pill) that prevents your body from absorbing too much salt and keeps your potassium levels from getting too low. Aldactone is used to d...
1960 May 9 The FDA announces it will approve Enovid 10mg the first contraceptive pill
Margaret Sanger, totally unaware that her lifelong dream had become reality, spent the day at her home outside Tucson, Ariz. Since 1914 she had battled ridicule and rigid laws, even gone ...
1961 Apr 7 FDA Approves AstraZeneca's Elavil
Elavil is the discontinued brand name for Amitriptyline that was manufactured by Astrazeneca. Elavil is a tricyclic antidepressant with sedative effects that was used in the treatment of ...
1964 Aug 10 FDA Approves Wellspring's Dyrenium
Treating swelling (edema) associated with conditions such as congestive heart failure, cirrhosis of the liver, and certain severe kidney problems (eg, nephrosis). It may be used alone or ...
1965 Jun 10 FDA Approves Iroko's Indocin
Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that reduces fever, pain and inflammation. It is similar to ibuprofen (Motrin) and naproxen (Naprosyn, Aleve). Indomethacin w...
1966 Jul 1 FDA Approves Sanofi-Aventis's Lasix
Lasix is a loop diuretic (water pill) that prevents your body from absorbing too much salt, allowing the salt to instead be passed in your urine. Lasix treats fluid retention (edema) i...
1966 Aug 19 FDA Approves Prometheus Labs' Zyloprim
Treating gout. It is used to treat high uric acid levels in the blood or urine caused by certain types of cancer chemotherapy. It is also used to treat certain patients with calcium oxala...
1967 Jan 10 FDA Approves Aton's Edecrin
Treating swelling due to congestive heart failure, liver problems, and severe kidney problems. It may also be used for other conditions as determined by your doctor. Edecrin is a loop ...
1968 Mar 20 FDA Approves Prometheus's Imuran
Preventing kidney transplant rejection along with other medicine. It may also be used to treat signs and symptoms of active rheumatoid arthritis. It may also be used for other conditions ...
1971 Jun 30 FDA Approves Medicis's Lidex
Treating inflammation and itching due to certain skin conditions. It may also be used for other conditions as determined by your doctor. Lidex Cream is a topical adrenocortical steroid...
1973 Jul 30 FDA Approves Mutual Pharm's Bactrim
Bactrim contains a combination of sulfamethoxazole and trimethoprim and is supplied in tablets and a liquid suspension. Sulfamethoxazole and trimethoprim are both antibiotics that treat d...
1974 Sep 19 FDA Approves McNEIL's Motrin
Motrin is a nonsteroidal anti-inflammatory drug available in both prescription and nonprescription forms. Prescription Motrin is used in adults for relief of the symptoms of rheumatoid ar...
1976 Mar 11 FDA Approves Roche Palo's Naprosyn
Naprosyn 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. Naprosyn is used...
1977 Sep 30 FDA Approves Biovail's Ativan
This medication is used to treat anxiety. Lorazepam belongs to a class of drugs known as benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming ef...
1977 Dec 30 FDA Approves AstraZeneca's Nolvadex
NOLVADEX is effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, NOLVADEX is an alternative to oophorectomy or ov...
1977 Dec 30 FDA Approves Novartis's Hydergine
Treating symptoms of declined mental capacity (memory, mood, and behavior problems) in certain patients older than 60 years of age. It may also be used for other conditions as determined ...
1978 FDA Approves Grifols Biological's Albutein
Treating a variety of conditions, including shock due to blood loss in the body, burns, low protein levels due to surgery or liver failure, and as an additional medicine in bypass surgery...
1978 Mar 1 FDA Approves Pharmacia and UpJohn's Psorcon
Psorcon is prescribed for the relief of the inflammation and itching of skin disorders that respond to the application of steroids (hormones produced by the body that have potent anti-inf...
1978 Aug 7 FDA Approves Troprol XL
Metoprolol also reduces the force of contraction of heart muscle and thereby lowers blood pressure. By reducing the heart rate and the force of muscle contraction, metoprolol reduces the ...
1981 Feb 27 FDA Approves Sandoz's Restoril
Restoril is a sleeping aid used in the short-term treatment of insomnia, a condition in which patients have difficulty falling asleep or staying asleep throughout the night. Restoril belo...
1981 Aug 19 FDA Approves AstraZeneca's Tenormin
Tenormin is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins). Tenormin is used to treat angina (chest pa...
1981 Oct 5 FDA Approves Paddock's Midamor
Preventing development of low blood potassium or helping to restore normal blood potassium in patients with high blood pressure or heart failure. It is usually used with other medicines. ...
1981 Oct 16 FDA Approves Pharmacia and UpJohn's Xanax
Xanax is a tranquilizer used in the short-term relief of symptoms of anxiety or the treatment of anxiety disorders. Anxiety disorder is marked by unrealistic worry or excessive fears and ...
1982 Oct 28 FDA Approves Lilly's Humulin N
Humulin N is an insulin injection for patients with type 1 and type 2 diabetes. Humulin N is a replicated version of human insulin hormone that is intended to treat diabetes symptoms up t...
1982 Nov 5 FDA Approves BTA's Cardizem to Lower Hypertension
Cardizem is a medication distributed by BTA Pharmaceuticals that is used to treat severe chest pain and high blood pressure. Cardizem works by affecting the movement of calcium into the c...
1982 Nov 15 FDA Approves Upjohn's Halcion
Halcion is used for short-term treatment of insomnia. It is a member of the benzodiazepine class of drugs, many of which are used as tranquilizers.
1982 Dec 14 FDA Approves GlaxoSmithKlein's Aclovate
This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Alclometasone reduces the swelling, itching, and redness that can occur in these...
1983 Feb 28 FDA Approves Validus's Bumex
Bumex is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occu...
1983 Nov 10 FDA Approves Bristol Myers Squibb's VePesid
Treating patients with lung cancer and recurrent testicular tumors. It is used in combination with other cancer medications. VePesid is an antineoplastic. It works by stopping the tumo...
1984 Jan 13 FDA Approves GlaxoSmithKline's Nicorette Gum
Nicorette gum is used as an aid in smoking cessation. It works by providing low levels of nicotine, which may help you to quit smoking by lessening the physical signs of withdrawal sympto...
1984 May 8 FDA Approves Pfizer's Glucotrol
Glucotrol is an oral diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin. Glucotrol is used together with diet and exercise to ...
1984 May 18 FDA Approves Wyeth's Advil
Advil (ibuprofen) is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen works by reducing hormones that cause inflammation and pain in the body. Advil ...
1985 Jan 25 FDA Approves GlaxoSmithKline's Zovirax
Zovirax (acyclovir) is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Zovirax will not cure herpes, but it can lessen ...
1985 May 31 FDA Approves Abbott's Marinol
Marinol (dronabinol) is a man-made form of cannabis (marijuana is an herbal form of cannabis). Dronabinol causes many effects on your central nervous system. Marinol is used to treat l...
1985 Dec 27 FDA Approves Galderma's Clobex Lotion to Treat Psoriasis
Treating inflammation and itching due to certain skin conditions. It is also used to treat moderate to severe psoriasis. It may also be used for other conditions as determined by your doc...
1985 Dec 30 FDA Approves GlaxoSmithKline's Wellbutrin
Bupropion (amfebutamone) (brand names Wellbutrin and Zyban) is an antidepressant of the aminoketone class, chemically unrelated to tricyclics or selective serotonin reuptake inhibitors (S...
1987 Mar 19 FDA Approves ViiV Healthcare's Retrovir
Treating HIV infection when used along with other medicines. It is also used with other medicines to help prevent women from passing the HIV virus to the fetus during pregnancy. Retrov...
1987 Apr 30 FDA Approves Schering-Plough's Elocon
Elocon is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling. Elocon is used to treat the inflammation and...
1987 Dec 29 FDA Approves Lilly's Prozac
Prozac is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Prozac affects chemicals in the brain that may become unbalanced and cause depressi...
1987 Dec 29 Prozac is Approved by the FDA
Fluoxetine hydrochloride had been approved for use in Belgium the year before. But the imprimatur of the U.S. Food and Drug Administration heralded a whole new era. At first, just scienti...
1988 Jul 28 FDA Approves Novartis's Voltaren
Voltaren is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Voltaren works by reducing hormones that cause inflammation and pain in the body. Voltaren is used...
1990 Dec 17 FDA Approves Ranbaxy's Ultravate
Treating inflammation and itching caused by certain skin conditions. It may also be used for other conditions as determined by your doctor. Ultravate Cream is a topical corticosteroid....
1991 Jun 28 FDA Approves Pharmacia and UpJohn's Adrucil
Treating symptoms of colon, rectum, breast, stomach, and pancreas cancer. Adrucil is an antimetabolite. It works by interfering with the production of proteins necessary for cell growt...
1991 Sep 27 FDA Approves AstraZeneca's Foscavir
Managing cytomegalovirus (CMV) retinitis (a viral infection that can lead to blindness) in patients with AIDS. It may also be used to treat resistant herpes simplex virus (HSV) of the ski...