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Status:
US Approved Rx
(1976)
Source:
NDA017697
(1976)
Source URL:
First approved in 1976
Source:
NDA017697
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Sincalide is a synthetically-prepared C-terminal octapeptide of naturally occurring hormone cholecystokinin. Sincalide causes gallbladder contraction and stimulates secretion of pancreatic enzymes, and this property of the drug is used in diagnostic purposes. It is discussed that the drug acts by binding and stimulating the CCK-A receptor which is expressed in the target tissues. FDA approved sincalide under the name KINEVAC.
Status:
US Approved Rx
(1993)
Source:
ANDA074201
(1993)
Source URL:
First approved in 1976
Source:
NDA017581
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Naproxen (naproxen sodium, NAPROSYN®) is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). It is an anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout. The mechanism of action of the naproxen (naproxen sodium, NAPROSYN®), like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Status:
US Approved Rx
(1989)
Source:
ANDA072575
(1989)
Source URL:
First approved in 1976
Source:
NDA017442
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Prazosin (trade names Minipress, Vasoflex, Lentopres, and Hypovase) is a selective α-1-adrenergic receptor antagonist used to treat hypertension. Prazosin acts by inhibiting the postsynaptic alpha-1-adrenoceptors on vascular smooth muscle. This inhibits the vasoconstrictor effect of circulating and locally released catecholamines (epinephrine and norepinephrine), resulting in peripheral vasodilation. Prazosin is orally active and has a minimal effect on cardiac function due to its alpha-1 receptor selectivity. However, when prazosin is started, heart rate and contractility go up in order to maintain the pre-treatment blood pressures because the body has reached homeostasis at its abnormally high blood pressure. The blood pressure lowering effect becomes apparent when prazosin is taken for longer periods of time. The heart rate and contractility go back down over time and blood pressure decreases. The antihypertensive characteristics of prazosin make it a second-line choice for the treatment of high blood pressure. Prazosin is also useful in treating urinary hesitancy associated with prostatic hyperplasia, blocking alpha-1 receptors, which control constriction of both the prostate and urethra. Although not a first line choice for either hypertension or prostatic hyperplasia, it is a choice for patients who present with both problems concomitantly. Common (4–10% frequency) side effects of prazosin include dizziness, headache, drowsiness, lack of energy, weakness, palpitations, and nausea. Less frequent (1–4%) side effects include vomiting, diarrhea, constipation, edema, orthostatic hypotension, dyspnea, syncope, vertigo, depression, nervousness, and rash.
Status:
US Approved Rx
(1996)
Source:
ANDA074582
(1996)
Source URL:
First approved in 1976
Source:
DANOCRINE by SANOFI AVENTIS US
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Danazol is a synthetic derivative of ethisterone which is approved by FDA for the treatment of endometriosis, fibrocystic breast disease and for preventing hereditary angioedema. It is believed that the in vivo therapeutic effect is achieved through activating androgen receptors. Danazol has teratogenic effects.
Status:
US Approved Rx
(1989)
Source:
ANDA071910
(1989)
Source URL:
First approved in 1976
Source:
SODIUM IODIDE I 123 by GE HEALTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Iodide ion I-123 is the most suitable isotope of iodine for the diagnostic study of thyroid diseases. Sodium Iodide I 131 Capsules Diagnostic is indicated for use in adults for: Assessment of thyroid function using radioactive iodine (RAI) uptake test and Imaging the thyroid (scintigraphy). The following adverse reaction has been described elsewhere in the labeling: Hypersensitivity Reactions. The following adverse reactions have been identified during post-approval use from Sodium Iodide I 131 Capsules Diagnostic: Gastrointestinal disorders (vomiting, nausea, and diarrhea); General disorders and administration site conditions (local thyroid swelling); Immune system disorders (hypersensitivity reactions); Skin and subcutaneous tissue disorders (itching, rash, hives, and erythema). Certain drugs and iodine-containing foods interfere with the accumulation of radioiodide by the thyroid.
Status:
US Approved Rx
(1976)
Source:
NDA017588
(1976)
Source URL:
First approved in 1976
Source:
NDA017588
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Lomustine is used in the treatment of certain neoplastic diseases. Although it is generally agreed that lomustine alkylates DNA and RNA, it is not cross resistant with other alkylators. As with other nitrosoureas, it may also inhibit several key enzymatic processes by carbamoylation of amino acids in proteins. Common adverse reactions include delayed myelosupression, nausea, vomiting, stomatitis, and alopecia.
Status:
US Approved Rx
(2022)
Source:
ANDA214475
(2022)
Source URL:
First approved in 1976
Source:
NALFON by KEY THERAP
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Fenoprofen is a propionic acid derivative with analgesic, antiinflammatory and antipyretic properties. Fenoprofen inhibits prostaglandin synthesis by decreasing the enzyme needed for biosynthesis. In patients with rheumatoid arthritis, the anti-inflammatory action of fenoprofen has been evidenced by relief of pain, increase in grip strength, and reductions in joint swelling, duration of morning stiffness, and disease activity (as assessed by both the investigator and the patient). In patients with osteoarthritis, the anti-inflammatory and analgesic effects of fenoprofen have been demonstrated by reduction in tenderness as a response to pressure and reductions in night pain, stiffness, swelling, and overall disease activity (as assessed by both the patient and the investigator). These effects have also been demonstrated by relief of pain with motion and at rest and increased range of motion in involved joints. In patients with rheumatoid arthritis and osteoarthritis, clinical studies have shown fenoprofen to be comparable to aspirin in controlling the aforementioned measures of disease activity, but mild gastrointestinal reactions (nausea, dyspepsia) and tinnitus occurred less frequently in patients treated with fenoprofen than in aspirin-treated patients. It is not known whether fenoprofen causes less peptic ulceration than does aspirin. In patients with pain, the analgesic action of fenoprofen has produced a reduction in pain intensity, an increase in pain relief, improvement in total analgesia scores, and a sustained analgesic effect. Indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Also for the relief of mild to moderate pain.
Status:
US Approved Rx
(2005)
Source:
ANDA077133
(2005)
Source URL:
First approved in 1976
Source:
VIRA-A by PARKEDALE
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Vidarabine or 9-β-D-arabinofuranosyladenine (ara-A, trade name Vira-A) is a synthetic purine nucleoside analog with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of Vidarabine is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts Vidarabine into Vidarabine monophosphate, a nucleotide analog. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. in vitro, Vidarabine triphosphate stops replication of herpes viral DNA. When used as a substrate for viral DNA polymerase, Vidarabine triphosphate competitively inhibits dATP leading to the formation of 'faulty' DNA. This is where Vidarabine triphosphate is incorporated into the DNA strand replacing many of the adenosine bases. This results in the prevention of DNA synthesis, as phosphodiester bridges can longer to be built, destabilizing the strand.
Status:
US Approved Rx
(1979)
Source:
NDA018058
(1979)
Source URL:
First approved in 1976
Source:
GALLIUM CITRATE GA 67 by LANTHEUS MEDCL
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Gallium citrate Ga 67 is the citrate salt of the radioisotope gallium Ga 67. Although the mechanism is unknown, gallium Ga 67 concentrates in lysosomes and is bound to a soluble intracellular protein in certain viable primary and metastatic tumors and focal sites of inflammation, allowing scintigraphic localization. Ga-67 scintigraphy (GS) cannot differentiate between tumor and acute inflammation. Gallium Citrate Ga 67 Injection may be useful in demonstrating the presence of the following malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma. Positive Ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state.
Status:
US Approved Rx
(2011)
Source:
ANDA091292
(2011)
Source URL:
First approved in 1976
Source:
IMODIUM by J AND J CONSUMER INC
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Loperamide is a commonly used over-the-counter (OTC) and prescription medicine that is approved to help control symptoms of diarrhea, including Travelers’ Diarrhea. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use. It is sold under the OTC brand name Imodium A-D, as store brands, and as generics. In vitro and animal studies show that IMODIUM® (loperamide hydrochloride) acts by slowing
intestinal motility and by affecting water and electrolyte movement through the bowel.
Loperamide binds to the opiate receptor in the gut wall. Consequently, it inhibits the release of
acetylcholine and prostaglandins, thereby reducing propulsive peristalsis, and increasing
intestinal transit time. Loperamide increases the tone of the anal sphincter, thereby reducing incontinence and urgency. Loperamide is also indicated for reducing the volume of discharge from ileostomies. In man, Loperamide prolongs the transit time of the intestinal contents. It reduces the daily fecal volume, increases the viscosity and bulk density, and diminishes the loss of fluid and electrolytes. Tolerance to the antidiarrheal effect has not been observed. Loperamide is an opioid receptor agonist and acts on the mu opioid receptors in the myenteric plexus large intestines; it does not affect the central nervous system like other opioids. It works specifically by decreasing the activity of the myenteric plexus which decreases the motility of the circular and longitudinal smooth muscles of the intestinal wall. This increases the amount of time substances stay in the intestine, allowing for more water to be absorbed out of the fecal matter. Loperamide also decreases colonic mass movements and suppresses the gastrocolic reflex.