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Search results for m root_references_citation in Reference Text / Citation (approximate match)
Status:
US Approved Rx
(2012)
Source:
NDA203993
(2012)
Source URL:
First approved in 2011
Source:
NDA202067
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Clobazam belongs to the 1,5-benzodiazepine class of drugs with antiepileptic properties. It has been used to treat anxiety and epilepsy since 1970s. In the US clobazam was approved for marketing in October of 2011 for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. It is also approved for adjunctive therapy for epilepsy in patients who have not responded to first-line drugs and in children who are refractory to first-line drugs. The mechanism of action for clobazam is not fully understood but is thought to involve what is known as potentiation of GABAergic neurotransmission resulting from binding at a benzodiazepine site at the GABA(A) receptor. Possible side effects: constipation, fever, drowsiness, sedation, ataxia, aggressive behavior, lethargy, drooling, and irritability. Other side effects include: urinary tract infection, pneumonia, cough, dysphagia, dysarthria, bronchitis, insomnia, fatigue, decreased appetite, and increased appetite.
Status:
US Approved Rx
(2021)
Source:
ANDA213729
(2021)
Source URL:
First approved in 2010
Source:
NDA022562
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Carglumic acid is a Carbamoyl Phosphate Synthetase 1 (CPS 1) allosteric modulator. CPS1 is found in the mitochondria and is the first enzyme of the urea cycle, which converts ammonia into urea. Carglumic acid acts as a replacement for NAG in NAGS deficiency patients by activating CPS1 but it does not help to regulate the urea cycle. Carglumic acid under the trade name Carbaglu indicated as adjunctive therapy for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS). In addition, as maintenance therapy for the treatment of chronic hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS). This rare genetic disorder results in elevated blood levels of ammonia, which can eventually cross the blood–brain barrier and cause neurologic problems, cerebral edema, coma, and death.
Status:
US Approved Rx
(2009)
Source:
NDA022268
(2009)
Source URL:
First approved in 2009
Source:
NDA022268
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Artemether is an antimalarial agent used to treat acute uncomplicated malaria. It is administered in combination with lumefantrine for improved efficacy against malaria. Artemether is rapidly metabolized into an active metabolite dihydroartemisinin (DHA). The antimalarial activity of artemether and DHA has been attributed to endoperoxide moiety. Artemethe involves an interaction with ferriprotoporphyrin IX (“heme”), or ferrous ions, in the acidic parasite food vacuole, which results in the generation of cytotoxic radical species. The generally accepted mechanism of action of peroxide antimalarials involves interaction of the peroxide-containing drug with heme, a hemoglobin degradation byproduct, derived from proteolysis of hemoglobin. This interaction is believed to result in the formation of a range of potentially toxic oxygen and carbon-centered radicals. Other mechanisms of action for artemether include their ability to reduce fever by production of signals to hypothalamus thermoregulatory center. Now, recent research has shown the presence of a new, previously unknown cyclooxygenase enzyme COX-3, found in the brain and spinal cord, which is selectively inhibited by artemether, and is distinct from the two already known cyclooxygenase enzymes COX-1 and COX-2. It is now believed that this selective inhibition of the enzyme COX-3 in the brain and spinal cord explains the ability of artemether in relieving pain and reducing fever which is produced by malaria. The most common adverse reactions in adults (>30%) are headache, anorexia, dizziness, asthenia, arthralgia and myalgia.
Status:
US Approved Rx
(2009)
Source:
NDA022192
(2009)
Source URL:
First approved in 2009
Source:
NDA022192
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Iloperidone, also known as Fanapt, Fanapta, and previously known as Zomaril, is an atypical antipsychotic for the treatment of schizophrenia. Iloperidone shows high affinity and maximal receptor occupancy for dopamine D2 receptors in the caudate nucleus and putamen of the brains of schizophrenic patients. The improvement in cognition is attributed to iloperidone's high affinity for α adrenergic receptors. Iloperidone also binds with high affinity to serotonin 5-HT2a and dopamine 3 receptors. Iloperidone binds with moderate affinity to dopamine D4, serotonin 5-HT6 and 5-HT7, and norepinephrine NEα1 receptors. Furthermore, iloperidone binds with weak affinity to serotonin 5-HT1A, dopamine D1, and histamine H1 receptors. Iloperidone is indicated for the treatment of acute schizophrenia.
Status:
US Approved Rx
(2023)
Source:
ANDA216811
(2023)
Source URL:
First approved in 2008
Source:
DHA by Mission Pharmacal Company
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Icosapent is an important polyunsaturated fatty acid found in fish oils. It serves as the precursor for the prostaglandin-3 and thromboxane-3 families. A diet rich in eicosapentaenoic acid lowers serum lipid concentration, reduces incidence of cardiovascular disorders, prevents platelet aggregation, and inhibits arachidonic acid conversion into the thromboxane-2 and prostaglandin-2 families. EPA can be used for lowering elevated triglycerides in those who are hyperglyceridemic. In addition, EPA may play a therapeutic role in patients with cystic fibrosis by reducing disease severity and may play a similar role in type 2 diabetics in slowing the progression of diabetic nephropathy.
Status:
US Approved Rx
(2020)
Source:
ANDA213450
(2020)
Source URL:
First approved in 2008
Source:
NDA022224
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Status:
US Approved Rx
(2017)
Source:
NDA209091
(2017)
Source URL:
First approved in 2008
Source:
NDA202293
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Dapagliflozin (trade name Farxiga in the U.S. and Forxiga in the EU and Russia) is a drug of the gliflozin class, developed by Bristol-Myers Squibb in partnership with AstraZeneca. Farxiga is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Status:
US Approved Rx
(2006)
Source:
NDA021471
(2006)
Source URL:
First approved in 2006
Source:
NDA021471
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Also called Ecamsule (technical name terephthalylidine dicamphor sulfonic acid), Mexoryl SX is a synthetic sunscreen agent developed and patented by L’Oreal and used in the company’s sunscreen products sold outside the United States since 1993 (approved for use in Europe in 1991). Ecamsule affords broad spectrum protection against the sun’s UVB and UVA rays. Exposed to UV, ecamsule undergoes reversible photoisomerization, followed by photoexcitation. The absorbed UV is then released as thermal energy, without penetrating the skin. The UVB range is 280 to 320 nanometers, and the UVA range is 320 to 400. Ecamsule protects against UV wavelengths in the 290–400 nanometer range, with peak protection at 345 nm.[3][4] Since ecamsule doesn't cover the entire UV spectrum, it should be combined with other active sunscreen agents to ensure broad-spectrum UV protection. Ecamsule is a photostable organic UVA absorber, meaning it doesn't degrade significantly when exposed to light.
Status:
US Approved Rx
(2010)
Source:
NDA022532
(2010)
Source URL:
First approved in 2005
Source:
Select OB by Everett Laboratories, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2019)
Source:
ANDA210281
(2019)
Source URL:
First approved in 2004
Source:
NDA021518
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Solifenacin is a competitive muscarinic acetylcholine receptor antagonist. The binding of acetylcholine to these receptors, particularly the M3 receptor subtype, plays a critical role in the contraction of smooth muscle. By preventing the binding of acetylcholine to these receptors, solifenacin reduces smooth muscle tone in the bladder, allowing the bladder to retain larger volumes of urine. It is FDA approved for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Common adverse reactions include constipation, Xerostomia. Inhibitors of CYP3A4 may increase the concentration of Solifenacin. Vice versa, CYP3A4 Inducers decrease concentration.