New Warnings for MS Drug Gilenya After FDA Review

New Warnings for MS Drug Gilenya After FDA Review

Filed under: drug treatment news 2011

But it may apply to them if they stop taking Gilenya for more than two weeks and need to restart the treatment. They would need to repeat the ECGs as well as the six-hour monitoring period. These changes follow an FDA report in December 2011 of an MS …
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Novartis drug Jakavi(TM) recommended by CHMP for EU approval to treat patients

Filed under: drug treatment news 2011

Novartis International AG / Novartis drug Jakavi(TM) recommended by CHMP for EU approval to treat patients with the life-threatening blood cancer myelofibrosis . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the …
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Addicts and treatment providers plead to halt state funding cuts

Filed under: drug treatment news 2011

By Rachel Dissell, The Plain Dealer COLUMBUS, Ohio — A bus loaded with more than 50 people involved with drug addiction and its treatment headed to Columbus this week to persuade lawmakers to reverse an expected $ 6.2 million in cuts to their programs.
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Proposed Christian substance abuse program on hold

Filed under: drug treatment news 2011

Wiseman Ministries planned to open the shelter and substance abuse treatment program in the former YWCA building in May. However, Shreveport's Downtown Development Authority contended that the organization's purpose for the building doesn't fit zoning …
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PDF file New And Notable Medications Approved In 2010 And 2011
review the pharmacology of newly approved drug therapies. by the Food and Drug Administration (FDA) in 2010 Fingolimod (Gilenya™) Fingolimod is an oral therapy for relapsing-remitting multiple sclerosis with Food and Drug Administration, New Molecular Entity Approvals for 2010, www.fda.gov/Drugs … Return Document

MOVING TOWARD A WORLD FREE OF MS | FALL 2010 GILENYA IS APPROVED
A second oral MS med is under review Last July, the FDA Gilenya is a powerful drug with potential side effects and risks as well as possibilities. The label carries warnings about these, including decreased heart rate after the first dose. development of a new oral drug for multiple sclerosis. … Return Document

About Death Of Patient On Gilenya Should Not Cause Panic
Taking this drug. The death occurred in a person after taking the first dose of Gilenya. few hours after the monitoring period. Due to the fact that Gilenya has been linked with these problems, the FDA also and I have 2 new lessions and the dr. wants me to try Gilenya. I’ve had MS … Read Article

Word file National PBM Monograph Template Rev20091005
Fingolimod (Gilenya®) National Drug Monograph. February 2011 monographs is to provide a comprehensive drug review for making formulary decisions. These documents will be updated when new is the first oral agent approved by the FDA as a disease modifying treatment for Multiple Sclerosis (MS). … View This Document

October Through December 2011
Gilenya (fingolimod)—Safety Review on Reported . Death: The FDA has received a report of a patient with . multiple sclerosis (MS) who died The drug will be manu-factured by Ohm Laboratories in New Brunswick, N.J. Ge-neric drugs approved by FDA have the the current warnings in the Chantix drug … Retrieve Content

PowerPoint file New Drug Review 2001: A Formulary Approach
Another LA Beta Agonist-Indacterol (Arcapta) An FDA advisory panel has voted 13-4 that a 75 inhibition of potassium channels Indication: to improve walking in adult patients with multiple sclerosis New Drug Review 2001: A Formulary Approach Author … Get Document

News EU Regulator To Rule On Novartis' MS Pill Gilenya Safety
EU Regulator To Rule On Novartis' MS Pill Gilenya Safety … Read News

PDF file New Drug Update
Objectives •Review new medications and significant dosage forms approved by FDA in atypical class warnings fixed dose, drug interactions New EnglJ Med 2010;362:387-401, 402-15, www.cardinal.com, www.gilenya.com Dalfampridine (Ampyra™) FDA Indication: improve walking in multiple sclerosis (MS) … Access Doc

PDF file Drug Class Review Of Disease Modifying drugs For Multiple …
Drug Class Review of Disease modifying drugs for Multiple Sclerosis identified one relevant systematic review. The search on the FDA website identified one new approved drug, no new March 2011 Warnings and … Access Full Source

News New Warnings For MS Drug Gilenya After FDA Review
Novartis, the maker of the drug Gilenya (fingolimod), a once-daily oral capsule taken for multiple sclerosis, has added stronger warnings to labels and prescription information about the drug’s possible heart risks, according to a company statement. … Read News

Word file Www.va.gov
FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod) FDA will communicate any new information on Gilenya and this case when it [See the Gilenya drug label for complete information on Warnings and … View Doc

PDF file 1-3 Medication Safety Seconds In
Gilenya – Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod) 12/20/2011 The FDA has alerted include warnings and strokes (3 new users, 5 switchers); 1 systemic embolism; and 1 acute myocardial infarction. Routine review of adverse drug … Fetch This Document