new FDA approved drugs 1


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new FDA approved drugs


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Recent FDA approved drugs :

Recent FDA approved drugs Sayed Syleem , M.Sc. Cardiologist Kafr Saad central hospital 2011

و في الأرضِ آياتٌ للموقنينَ * و في أنفُسِكم أفلا تُبْصِرونَ * :

و في الأرضِ آياتٌ للموقنينَ * و في أنفُسِكم أفلا تُبْصِرونَ * الذاريات 20 و 21

Gralise (gabapentin):

Gralise ( gabapentin ) Abbott Approved February 2011 Post-herpetic neuralgia

Mechanism of Action:

Mechanism of Action Gralise is an extended release formulation of gabapentin . Gabapentin is a gamma-amino-butyric acid (GABA), analogue. The mechanism of action by which gabapentin exerts its analgesic action is unknown but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli).

Abstral (fentanyl sublingual tablets):

Abstral ( fentanyl sublingual tablets) ProStrakan Approved January 2011 Breakthrough cancer pain in opioid-tolerant patients

PowerPoint Presentation:

Abstral is a sublingual tablet formulation of fentanyl citrate, a potent opioid analgesic. The precise mechanism of the analgesic action is unknown although fentanyl is known to be a µ- opioid receptor agonist. Specific CNS opioid receptors for endogenous cpds with opioid -like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug. Mechanism of Action

Viibryd (vilazodone HCl):

Viibryd ( vilazodone HCl ) Clinical Data Approved January 2011 Major depressive disorder

Mechanism of Action:

Vilazodone hydrochloride is a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. The mechanism of the antidepressant effect of vilazodone is not fully understood but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT1A receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown. Mechanism of Action

Makena (hydroxy-progesterone caproate injection):

Makena ( hydroxy -progesterone caproate injection) Hologic Approved February 2011 Preterm birth

Mechanism of Action:

Hydroxy-progesterone caproate is a synthetic progestin. The mechanism by which it reduces the risk of recurrent preterm birth is not known. Mechanism of Action

Pradaxa (dabigatran etexilate mesylate):

Pradaxa ( dabigatran etexilate mesylate ) Boehringer Ingeleheim Approved October 2010 Risk reduction of stroke and embolism due to atrial fibrillation

Mechanism of Action:

Dabigatran etexilate mesylate is a competitive, direct thrombin inhibitor. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are inhibited by the active moieties. Mechanism of Action

Herceptin (trastuzumab):

Herceptin ( trastuzumab ) Genentech Approved October 2010 Gastric cancer

Mechanism of Action:

Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein (HER2). HER2 is a cell membrane surface-bound receptor tyrosine kinase and is normally involved in the signal transduction pathways leading to cell growth and differentiation. HER2 is over- expresed in certain cancers. Mechanism of Action

Zuplenz (ondansetron oral soluble film):

Zuplenz ( ondansetron oral soluble film) Strativa Pharmaceuticals Approved July 2010 Post-operative, chemotherapy and radiotherapy induced nausea and vomiting

Mechanism of Action:

Ondansetron is a selective 5-HT3 receptor antagonist. Mechanism of Action

Krystexxa (pegloticase):

Krystexxa ( pegloticase ) Savient Pharma Approved September 2010 Chronic gout (hyperuricemia)

Mechanism of Action:

Krystexxa is a uric acid specific enzyme which is a PEGylated product that consists of recombinant modified mammalian urate oxidase ( uricase ) produced by a genetically modified strain of Escherichia coli. It achieves its therapeutic effect by catalyzing the oxidation of uric acid to allantoin , thereby lowering serum uric acid. Allantoin is an inert and water soluble purine metabolite. It is readily eliminated, primarily by renal excretion. Mechanism of Action

Xiaflex (collagenase clostridium histolyticum):

Xiaflex ( collagenase clostridium histolyticum ) Auxilium Pharmaceuticals Approved February 2010 Dupuytren’s contracture

Mechanism of Action:

Xiaflex contains purified collagenase clostridium histolyticum , consisting of two microbial collagenases in a defined mass ratio, Collagenase AUX-I and Collagenase AUX-II, which are isolated and purified from the fermentation of Clostridium histolyticum bacteria. Collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits. Injection of Xiaflex into a Dupuytren’s cord, which is comprised mostly of collagen, may result in enzymatic disruption of the cord. Mechanism of Action

Carbaglu (carglumic acid):

Carbaglu ( carglumic acid) Recordati Approved March 2010 Hyperammonemia

Mechanism of Action:

Carbaglu contains the active substance carglumic acid, a synthetic structural analogue of N-acetyl-glutamate (NAG), which is an essential allosteric activator of carbamoyl phosphate synthetase 1 (CPS 1) in liver mitochondria. CPS 1 is the first enzyme of the urea cycle, which converts ammonia into urea. NAG is the product of N-acetyl-glutamate synthase (NAGS), a mitochondrial enzyme. Carglumic acid acts as a replacement for NAG in NAGS deficiency patients by activating CPS 1. Mechanism of Action

Xifaxan (rifaximin):

Xifaxan ( rifaximin ) Salix Approved March 2010 Hepatic encephalopathy

Mechanism of Action:

Rifaximin is a non-amino-glycoside semi-synthetic, non-systemic antibiotic derived from rifamycin. Rifaximin acts by binding to the beta-subunit of bacterial DNA-dependent 507 RNA polymerase resulting in inhibition of bacterial RNA synthesis. Mechanism of Action

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