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Medications Approved by FDA in 2010 & 2009 

Contributed by Mohammad Saleem R.Ph.

 

 Victoza (liraglutide)

(type 2 diabetes mellitus) liraglutide, an analog of    human GLP-1 and acts as a GLP-1 receptor agonist. Liraglutide increases        intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations.

Actemra (tocilizumab)

Actemra is a recombinant humanized anti-human   interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1 kappa. It binds specifically to IL6 receptors. IL6 is a pro-inflammatory cytokine produced by a variety of cell types, including T- and B-cells, lymphocytes,       monocytes and fibroblasts.

Actemra us specifically    indicated for the treatment of adult patients with moderately to severely active    rheumatoid arthritis who have had an inadequate  response to one or more TNF antagonist therapies

Ampyra (dalfampridine)

Ampyra (dalfampridine) is a potassium channel blocker that enhances conduction in damaged nerves. The exact mechanism by which dalfampridine exerts its therapeutic effect has not been fully elucidated.

Ampyra is specifically inidicated as a treatment to improve walking in patients

with multiple sclerosis

Adcirca (tadalafil)

 

Embeda is specifically     indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time

Saphris (asenapine)

Saphris (asenapine) is a   sublingual psychotropic agent. The exact mechanism of action is unknown. However, it has been suggested that the efficacy of asenapine in schizophrenia is mediated through a combination of antagonist activity at D2 and 5-HT2A receptors.

Saphris is specifically indicated for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar          1 disorder with or without psychotic features in adults

Onglyza (saxagliptin)

Onglyza (saxagliptin) is an orally-active inhibitor of the DPP4 enzyme. D-PP4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins. Incretins decrease blood sugar by increasing consumption of sugar by the body, mainly through increasing insulin production in the pancreas, and by reducing production of sugar by the liver.

Onglyza is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

 

Adcirca (tadalafil) is an oral inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP). Pulmonary hypertension is the result of upregulation of PDE5 gene expression, causing vasoconstriction in the lung. Inhibition of PDE5 by tadalafil increases the concentrations of cGMP resulting in elaxation of pulmonary vascular smooth muscle cells and vasodilation of the pulmonary vascular bed.

Adcirca is specifically indicated for the treatment of pulmonary arterial           hypertension

Bepreve (bepotastine besilate ophthalmic solution) Bepreve is specifically indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis

Embeda (morphine sulfate and naltrexone hydrochloride) Embeda is an extended-release oral formulation of morphine sulfate and naltrexone     hydrochloride. Morphine   sulfate is an agonist and naltrexone hydrochloride is an antagonist at the         mu-opioid receptor. Morphine provides analgesic and sedative effects while naltrexone hydrochloride reverses the subjective and analgesic effects.