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Status:
Possibly Marketed Outside US
Source:
Fenthion by Brady, U.E.|Arthur, B.W.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Fenthion (trade names
include Baytex™, Baycid™, and
Tiguvon™, used on livestock)
was first registered domestically
in 1965 by the Mobay Corp., a
U.S. subsidiary of Bayer AG of
West Germany. Fenthion is a contact and stomach insecticide used against many sucking, biting pests, especially fruit flies, stem borers, mosquitoes, and Eurygaster cereal bugs. In mosquitoes, it is toxic to both the adult and immature forms (larvae). Once used extensively in the U.S. for controlling intestinal worms, fenthion no longer has FDA approval due to an excess number of poisoning deaths. Like most other organophosphates, its mode of action is via cholinesterase inhibition. It was used mostly for the control of grubs and lice in beef and nonlactating cattle.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ACHIRAL)
Anethole trithione or anetholtrithione is a drug used in the treatment of dry mouth. Anethole trithione is a bile secretion-stimulating drug that restores salivation. It is listed in the U.S. National Cancer Institute's Dictionary of Cancer Terms as being studied in the treatment of cancer. Anethol has also been identified as a treatment for improving medium and severe dry eye symptoms. The mechanism of action for the chemopreventive and xerostomia properties have not been fully elucidated.
Status:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Methoxychlor is a contact and stomach insecticide effective against a wide range of pests encountered in agriculture, households, and ornamental plantings. It was registered for use on fruits, vegetables, forage crops and on shade trees. Methoxychlor was also registered for veterinary use as a poison to kill parasites on dairy and beef cattle. Exposure to methoxychlor may occur during its manufacture or use as a pesticide. In an acute oral study in animals, changes in the liver were reported. Dermal contact with methoxychlor is slightly irritating to the skin. The use of methoxychlor as a pesticide was banned in the United States in 2003 and in the European Union in 2002.
Status:
US Approved Rx
(2014)
Source:
ANDA200910
(2014)
Source URL:
First approved in 2001
Source:
ORTHO EVRA by JANSSEN PHARMS
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Norelgestromin, the progestin, is the active metabolite of norgestimate and is structurally related to 19-nortestosterone. Norgestimate and norelgestromin mimic the physiologic effects of progesterone at the progesterone receptor. Johnson & Johnson developed an adhesive female contraceptive patch that contains ethinylestradiol (0.75mg) and the progestogen norelgestromin (6mg). his product is a combination contraceptive acting via the inhibition gonadotropins. Its primary mechanism of action involves the suppression of ovulation, including changes in the cervical mucus and endometrium. The patch delivers a continuous flow of hormones through the skin and into the bloodstream. The contraceptive patch is available in countries worldwide.
Status:
US Approved Rx
(2015)
Source:
ANDA200383
(2015)
Source URL:
First approved in 1989
Source:
ORTHO CYCLEN-21 by JANSSEN PHARMS
Source URL:
Class:
MIXTURE
Targets:
Norgestimate is a steroidal progestin of the 19-nortestosterone group that is used in combination with ethinylestradiol as an oral contraceptive and for treatment of acne. and in combination with estradiol in menopausal hormone replacement therapy. Norgestimate shows high selectivity for the progesterone receptor and low androgenic activity.
Status:
US Approved Rx
(2000)
Source:
ANDA075014
(2000)
Source URL:
First approved in 1986
Source:
NIX by GLAXOSMITHKLINE
Source URL:
Class:
MIXTURE
Targets:
Permethrin is a synthetic pyrethrin derivative acts as a neurotoxin by depolarizing the nerve cell membrane. Permethrin disrupts the sodium channel current by which membrane repolarization is regulated resulting in fatal paralysis of the nerves in the exoskeletal respiratory muscles of susceptible arthropods, including lice and mite. Permethrin is sold under brand names NIx and Elimite to treat pediculosis, scabies and demodicidosis.
Status:
US Approved Rx
(2024)
Source:
NDA216158
(2024)
Source URL:
First approved in 2024
Source:
NDA216158
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Xanomeline (LY-246,708) is an orthosteric muscarinic acetylcholine receptor (mAChR) agonist, often referred to as M1/M4-preferring. It is also known to act as a M5 receptor antagonist. Xanomeline was studied in clinical trials phase I in schizophrenia. In Phase II clinical trials in Alzheimer’s patients, xanomeline significantly improved several measures of cognitive function, yet produced unwanted side effects that limited patient compliance. The side effects seem to be associated with rapid metabolism of the alkyloxy side chain following oral administration, resulting in a nonselective, yet active compound with limited therapeutic utility. Despite a second Phase II clinical trial with a patch formulation, the liabilities of xanomeline still outweigh its benefits.
Status:
US Approved Rx
(2024)
Source:
NDA216158
(2024)
Source URL:
First approved in 2024
Source:
NDA216158
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Xanomeline (LY-246,708) is an orthosteric muscarinic acetylcholine receptor (mAChR) agonist, often referred to as M1/M4-preferring. It is also known to act as a M5 receptor antagonist. Xanomeline was studied in clinical trials phase I in schizophrenia. In Phase II clinical trials in Alzheimer’s patients, xanomeline significantly improved several measures of cognitive function, yet produced unwanted side effects that limited patient compliance. The side effects seem to be associated with rapid metabolism of the alkyloxy side chain following oral administration, resulting in a nonselective, yet active compound with limited therapeutic utility. Despite a second Phase II clinical trial with a patch formulation, the liabilities of xanomeline still outweigh its benefits.
Status:
US Approved Rx
(2023)
Source:
NDA216873
(2023)
Source URL:
First approved in 2023
Source:
NDA216873
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Momelotinib (CYT387) is an ATP-competitive small molecule that potently inhibits JAK1/JAK2 kinases. Momelotinib is developing by Gilead Sciences for the oral treatment of pancreatic and non-small cell lung cancers, and myeloproliferative disorders (including myelofibrosis, essential thrombocythaemia and polycythaemia vera).
Status:
US Approved Rx
(2023)
Source:
NDA216386
(2023)
Source URL:
First approved in 2023
Source:
NDA216386
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Zavegepant is a third generation, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist being developed by Pfizer, under a license from Bristol-Myers Squibb, for the prevention and treatment of chronic and episodic migraine. In March 2023, zavegepant nasal spray (ZAVZPRET™) received its first approval in the USA for the acute treatment of migraine with or without aura in adults, based on two randomized, double-blind, placebo-controlled studies. Clinical development of an oral formulation of zavegepant is currently underway.