Pfizer’s Xalkori Granted Regular FDA Approval

New Drug Approvals

Pfizer’s XALKORI® Granted Regular FDA Approval
Standard of Care for Patients With Metastatic ALK-Positive Non-Small Cell Lung Cancer

NEW YORK, November 21, 2013–(BUSINESS WIRE)–Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Pfizer’s XALKORI® (crizotinib) regular approval for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. XALKORI was previously granted accelerated approval in August 2011 due to the critical need for new agents for people living with ALK-positive NSCLC

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http://www.pharmalive.com/pfizer%E2%80%99s-xalkori-granted-regular-fda-approval

http://newdrugapprovals.wordpress.com/2013/03/01/pfizer-gains-china-approval-of-kinase-specific-lung-cancer-drug-xalkori-crizotinib/

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Europace Publishes Data Supporting Use Of BRINAVESS™ (Vernakalant) As A First Line Agent For Pharmacological Cardioversion Of Atrial Fibrillation

New Drug Approvals

Vernakalant, MK-6621, RSD 1235

(3R)-1-{(1R,2R)-2-[2-(3,4-dimethoxyphenyl)
ethoxy]cyclohexyl}pyrrolidin-3-ol

C20H31NO4 ,  349.47, Brinavess , Kynapid

cas no 794466-70-9 
748810-28-8 (HCl)

EMA:Link  click here

PATENT   WO 2004099137

VANCOUVER, Nov. 21, 2013 /PRNewswire/ – Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that a publication titled, Pharmacological Cardioversion of Atrial Fibrillation with Vernakalant: Evidence in Support of the ESC Guidelines, was published in Europace, the official Journal of the European Heart Rhythm Association, and was made available in the advanced online article access section. The authors conclude that BRINAVESS is an efficacious and rapid acting pharmacological cardioversion agent, for recent-onset atrial fibrillation (AF,) that can be used first line in patients with little or no underlying cardiovascular disease and in patients with moderate disease, such as stable coronary and hypertensive heart disease.

http://www.prnewswire.com/news-releases/europace-publishes-data-supporting-use-of-brinavess-vernakalant-as-a-first-line-agent-for-pharmacological-cardioversion-of-atrial-fibrillation-232816731.html

Vernakalant (INN; codenamed RSD1235, proposed tradenames Kynapid and 

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CHINESE MEDICINE-Xuezhikang , A blood lipid regulator

New Drug Approvals

Xuezhikang

Xuezhikang, the extract of red yeast rice, has been widely used as a Chinese traditional medicine for the therapy of patients with cardiovascular diseases. It contains natural Lovastatin and its homologues, as well as unsaturated fatty acids, flavonoids, plant sterols and other biologically active substances

The product is a world-recognized blood lipid regulator, which is made by extracting from “specially-made red yeast rice”. It combines modern high-tech biotechnology with traditional Chinese medicine, which can safely and effectively regulate blood lipids in a comprehensive way with proven curative effects and reliable safety.

Pharmacological Effects: the product can reduce blood cholesterol, triglycerides, low density lipoprotein cholesterol, improve high density lipoprotein cholesterol, inhibit atherosclerotic plaque formation, and protect vascular endothelial cells; and inhibit lipid deposition in the liver. The large-scale evidence-based research has proven that long-term use of XUEZHIKANG can greatly reduce the risk of CHD occurrence and decrease the mortality. XUEZHIKANG…

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Zucapsaicin (Zuacta)

New Drug Approvals

Chemical structure of zucapsaicin

Zucapsaicin (Zuacta), cas 25775-90-0

Chemical name: (Z)-8-methyl-N-vanillyl-6-nonenamide
Molecular formula: C18H27NO3
Molecular mass: 305.41

E merck

Civamide, cis-Capsaicin,

Civanex (zucapsaicin) cream is a TRPV-1 modulator in development for the treatment of signs and symptoms of osteoarthritis of the knee.
Zucapsaicin, the cis-isomer of the natural product capsaicin, is a
topical analgesic that was initially developed by Winston Pharmaceuticals
and approved in Canada in July 2010 for the treatment of
severe pain in adults with osteoarthritis of the knee.

Bronson, J.; Dhar, M.; Ewing, W.; Lonberg, N. In Annual Reports in MedicinalChemistry; John, E. M., Ed.; Academic Press, 2011; Vol. 46, p 433.

The advantagesof zucapsaicin compared with naturally-occurring capsaicin, are reported to be a lesser degree of local irritation (stinging, burning,

erythema) in patients and a greater degree of efficacy in preclinical
animal models of pain.

Bernstein, J. E. U.S. 5063060, 1991.
Bernstein, J. E. U.S. 20050084520 A1, 2005.

The analgesic action…

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EYLEA® (aflibercept) Injection Approved For The Treatment of Macular Edema Following Central Retinal Vein Occlusion In Japan

New Drug Approvals

TARRYTOWN, N.Y., Nov. 22, 2013 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that EYLEA® (aflibercept) Injection has received approval for the treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO) from the Japanese Ministry of Health, Labour and Welfare.http://www.pharmalive.com/japan-approves-eylea

In November 2011 the United States Food and Drug Administration approved aflibercept for the treatment of wet macular degeneration.

On August 3, 2012 the United States Food and Drug Administration approved Zaltrap (ziv-aflibercept) for use in combination with 5-fluorouracil, leucovorin and irinotecan to treat adults with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin‑containing regimen.

In November 2012 the European Medicines Agency (EMA) approved aflibercept for the treatment of wet macular degeneration.

On February 1, 2013 the European Commission granted a marketing authorisation valid throughout the European Union for treatment of adults with metastatic colorectal cancer for whom treatment based on oxaliplatin…

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Bristol-Myers Squibb files NDA in Japan for all-oral hepatitis C treatment

New Drug Approvals

Bristol-Myers Squibb has filed a new drug application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency for the approval of an interferon-free and ribavirin-free treatment regimen for patients with chronic hepatitis C (HCV).

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Bristol-Myers Squibb files NDA in Japan for all-oral hepatitis C treatment

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Pfizer Receives FDA Approval for a Prior Approval Supplement for EMBEDA® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII

New Drug Approvals

NEW YORK, November 04, 2013–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved a Prior Approval Supplement for EMBEDA® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII.

The Prior Approval Supplement included an update to the EMBEDA manufacturing process that addressed the pre-specified stability requirement that led to the voluntary recall of EMBEDA from the market in March 2011. Pfizer anticipates product availability in the second quarter of 2014.

http://www.pharmalive.com/fda-oks-prior-approval-supplement-for-embeda

 

 

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