New Drug Approvals


105826-92-4 (HCl)

 ICF 205-930, Navoban™
Molecular Formula: C17H20N2O2   Molecular Weight: 284.3529

Novartis (Originator)

Tropisetron (INN) is a serotonin 5-HT3 receptor antagonist used mainly as an antiemetic to treat nausea and vomiting following chemotherapy, although it has been used experimentally as an analgesic in cases of fibromyalgia.[1] The drug is available in a 5 mg oral preparation or in 2 mg intravenous form. It is marketed by Novartis in Europe, Australia, New Zealand, Japan, South Korea and the Philippines as Navoban, but is not available in the U.S. It is also available from Novell Pharmaceutical Laboratories and marketed in several Asian countries as Setrovel

Tropisetron is a 5-hydroxytryptamine receptor 3 (5-HT3) antagonist that was launched in 1992 by Novartis for the oral and injection treatment of chemotherapy-induced emesis. The drug has also been approved for the prophylaxis and treatment…

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Bayer, Onyx win early FDA OK for Nexavar (sorafenib) in thyroid cancer

New Drug Approvals

The U.S. Food and Drug Administration said on Friday it has expanded the approved use of the cancer drug Nexavar to include late-stage differentiated thyroid cancer.

Differentiated thyroid cancer is the most common type of thyroid cancer, the FDA said. The National Cancer Institute estimates that 60,220 people in the United States will be diagnosed with it and 1,850 will die from the disease in 2013.

The drug, made by Germany’s Bayer AG and Onyx Pharmaceuticals, is already approved to treat advanced kidney cancer and liver cancer that cannot be surgically removed. Onyx was acquired by Amgen Inc earlier this year.



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Otsuka and Lundbeck’s Once-Monthly Abilify Maintena(R) (Aripiprazole) Now Approved in Europe

New Drug Approvals

Otsuka and Lundbeck’s Once-Monthly Abilify Maintena(R) (Aripiprazole) Now Approved in Europe for Maintenance Treatment of Schizophrenia in Adult Patients Stabilized with Oral Aripiprazole

do not forget to see my old blog post, contains synthesis

Preventing relapse is critical in the treatment of schizophrenia. Pivotal studies, that supported the EU submission, demonstrate that Abilify Maintena can reduce the risk of relapse relative to placebo and is non-inferior to oral aripiprazole in patients with schizophrenia1,2 -- The approval of Abilify Maintena now provides patients with schizophrenia access to a once-monthly formulation with established efficacy together with a tolerability profile that is comparable to that of oral ABILIFY(R) (aripiprazole)2 -- At the end of the randomized, double-blind treatment phase in one of the pivotal trials, 93 percent of patients reported being extremely, very or somewhat satisfied with Abilify Maintena treatment3 -- Abilify Maintena is the only dopamine D2 partial agonist in a once-monthly…

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FDA Approves Olysio (simeprevir) for Hepatitis C Virus

New Drug Approvals


Inhibits HCV NS3/4A protease.

MEDIVIR … originator

launched 2013

923604-59-5  CAS

C38H47N5O7S MF

749.93908  MW

IUPAC standard name
(1R, 4R, 6S, 15R, 17R)-N-(cyclopropanesulfonyl) -17 – ({7-methoxy-8-methyl-2-[4 – (propan-2-yl) -1,3-thiazol-2 -yl] quinolin-4-yl} oxy)-13-methyl-2 ,14-dioxo-3 ,13-diazatricyclo [ 4 , 6 ] octadec-7-ene-4-carboxamide
IUPAC traditional name
(1R, 4R, 6S, 15R, 17R)-N-(cyclopropanesulfonyl) -17 – {[2 – (4-isopropyl-1 ,3-thiazol-2-yl)-7-methoxy-8-methylquinolin-4- yl] oxy}-13-methyl-2 ,14-dioxo-3 ,13-diazatricyclo [ 4 , 6 ] octadec-7-ene-4-carboxamide

  • Olysio
  • Simeprevir
  • TMC 435
  • TMC 435350
  • TMC-435
  • TMC435
  • TMC435350

November 22, 2013 — The U.S. Food and Drug Administration  approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.

OLYSIO™ is the first once-daily protease inhibitor approved for the treatment of chronic hepatitis C in a combination antiviral regimen for adults with compensated liver disease

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with…

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