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DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

Upsher-Smith Receives Tentative NDA Approval for Vogelxo™ (testosterone) Gel CIII

 GENERIC  Comments Off on Upsher-Smith Receives Tentative NDA Approval for Vogelxo™ (testosterone) Gel CIII
Aug 202013
 

MAPLE GROVE, Minn., Aug. 16, 2013 /PRNewswire/ — Upsher-Smith Laboratories, Inc., today announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Vogelxo™ (testosterone) gel for topical use CIII

http://www.pharmalive.com/upsher-smith-gets-tentative-nda-approval-for-vogelxo-gel

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Vibativ Back on the Market

 companies  Comments Off on Vibativ Back on the Market
Aug 162013
 

 

 

Theravance Inc. said Wednesday it is antibiotic Vibativ is now back on the market. Vibativ was approved as a treatment for complex skin infections in 2010, and it was approved for use against hospital-acquired pneumonia in June 2013. It is Theravance’s only approved drug.

 

read all at

http://www.dddmag.com/news/2013/08/vibativ-back-market?et_cid=3425506&et_rid=523035093&type=cta

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Actavis Receives Approval from French Competition Authority for Pending Warner Chilcott Acquisition

 Uncategorized  Comments Off on Actavis Receives Approval from French Competition Authority for Pending Warner Chilcott Acquisition
Aug 102013
 

 

PARSIPPANY, N.J. and DUBLIN, IRELAND – August 9, 2013 – Actavis, Inc. (NYSE: ACT) and Warner Chilcott plc (NASDAQ: WCRX) today announced that they have received approval from the French Competition Authority for Actavis’ pending acquisition of Warner Chilcott. The companies previously received approval from the German Federal Cartel Office and have now received all ex-U.S. antitrust clearances required to complete the transaction.

read all at

http://www.pharmalive.com/french-authorities-approve-actavis-acquisition-of-warner-chilcott

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Bethlehem

 

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Aug 072013
 

AZATHIOPRINE

generic licensing news

http://newsletter.lead-doctors.com/ef1/preview_campaign.php?lf1=932543337a665012625317e9856877

 

Azathioprine is a chemotherapy drug, now rarely used for chemotherapy but more for immunosuppression in organ transplantation and autoimmune disease such as rheumatoid arthritis or inflammatory bowel disease or Crohn’s disease. It is a pro-drug, converted in the body to the active metabolite 6-mercaptopurine. Azathioprine acts to inhibit purine synthesis necessary for the proliferation of cells, especially leukocytes and lymphocytes. It is a safe and effective drug used alone in certain autoimmune diseases, or in combination with other immunosuppressants in organ transplantation.
Click here to contact Douglas Pharmaceuticals about this product.

Azathioprine was synthesized by George Herbert Hitchings and Gertrude Elion in 1957 (named BW 57-322) to produce 6-mercaptopurine (6-MP) in a metabolically active but masked form, and at first used as a chemotherapy drug.

Robert Schwartz investigated the effect of 6-MP on the immune response in 1958 and discovered that it profoundly suppresses the formation of antibodies when given to rabbits together with antigens. Following the work done by Sir Peter Medawar and Gertrude Elion in discovering the immunological basis of rejection of transplanted tissues and organs, and Schwartz’s researches on 6-MP, Sir Roy Calne, the British pioneer in transplantation, introduced 6-MP as an experimental immunosuppressant for kidney and heart transplants. When Calne asked Elion for related compounds to investigate, she suggested azathioprine, which was subsequently found out to be superior (as effective and less toxic to the bone marrow) by Calne. On 5 April 1962, with regimens consisting of azathioprine and prednisone, the transplantation of kidneys to unrelated recipients (allotransplantation) was successful for the first time.For many years, this kind of dual therapy with azathioprine and glucocorticoids was the standard antirejection regimen, until ciclosporin was introduced into clinical practice (by Calne as well) in 1978.Ciclosporin has now replaced some of the azathioprine use due to a longer survival time, especially in heart-related transplantations.Moreover, despite being considerably more expensive, mycophenolate mofetil is also increasingly being used in place of azathioprine in organ transplantation, as it is associated with less bone marrow suppression, fewer opportunistic infections, and a lower incidence of acute rejection

Azathioprine is a thiopurine linked to a second heterocycle (an imidazole derivative) via a thioether. It is a pale yellow solid with a slightly bitter taste and a melting point of 238–245 °C. It is practically insoluble in water and only slightly soluble in lipophilic solvents such as chloroform, ethanol and diethylether. It dissolves in alkaline aqueous solutions, where it hydrolyzes to 6-mercaptopurine.

Azathioprine is synthesized from 5-chloro-1-methyl-4-nitro-1H-imidazole and 6-mercaptopurine in dimethyl sulfoxide (DMSO). The synthesis of the former starts with an amide from methylamine and diethyl oxalate, which is then cyclizised and chlorinated with phosphorus pentachloride; the nitro group is introduced with nitric and sulfuric acid.

The whole process of azathioprine synthesis

Azathioprine (INN, /ˌæzəˈθɵprn/, abbreviated AZA) is an immunosuppressive drug used in organ transplantation and autoimmune diseases and belongs to the chemical class of purine analogues.[1] Synthesized originally as a cancer drug and a prodrug for mercaptopurine in 1957, it has been widely used as an immunosuppressant for more than 50 years.[2]

Azathioprine acts as a prodrug for mercaptopurine, inhibiting an enzyme that is required for the synthesis of DNA. Thus it most strongly affects proliferating cells, such as the T cells and B cells of the immune system.[3][4]

The main adverse effect of azathioprine is bone marrow suppression, which can be life-threatening, especially in people with a genetic deficiency of the enzyme thiopurine S-methyltransferase.[5] It is also listed by the International Agency for Research on Cancer as a Group 1 carcinogen (carcinogenic to humans).[6]

Azathioprine is produced by a number of manufacturers under different brand names (Azasan by Salix in the U.S., Imuran by GlaxoSmithKline in Canada, the U.S., Australia, Ireland and Great Britain, Azamun in Finland and Imurel in Scandinavia and France, among others).

Azathioprine is used alone or in combination with other immunosuppressive therapy to prevent rejection following organ transplantation, and to treat an array of autoimmune diseases, including rheumatoid arthritis, pemphigus, systemic lupus erythematosus, Behçet’s disease and other forms of vasculitis, autoimmune hepatitis, atopic dermatitis, myasthenia gravis, neuromyelitis optica (Devic’s disease), restrictive lung disease, and others. It is also an important therapy and steroid-sparing agent for inflammatory bowel disease (such as Crohn’s disease and ulcerative colitis) and for multiple sclerosis, which are immune-mediated as well.

In the United States it is currently approved by the Food and Drug Administration (FDA) for use in kidney transplantation from human donors, and for rheumatoid arthritis. Other uses are off-label.

 

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Aug 052013
 

 the above is only a snap shot, see original animation at the link below

http://www.medindia.net/animation/patent-ductus-arteriosus.asp

You require a Flash plug-in version 8.0 or higher to view the animations. – Download Flash Player 

Read more: 

Health Animation – Patent Ductus Arteriosus (PDA) | Medindia http://www.medindia.net/animation/patent-ductus-arteriosus.asp#ixzz2b42Wqmvy

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Aug 012013
 
The prevalence of diabetes is growing globally, and with that the size of the diabetes drug market. There are more than 370 million people in the world with diabetes, about 90% of those with Type 2 diabetes. More children are developing the disease and more people are dying from diabetes, and so more and more people need treatment. Standard & Poor’s has estimated the annual market will hit $58 billion by 2018, from about $35 billion today.Read more:

http://www.fiercepharma.com/special-reports/10-top-selling-diabetes-drugs-2012?page=0,0&utm_medium=nl&utm_source=internal

 

 

check these videos

 

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