FDA, Copaxone and multiple sclerosis

Teva's multiple sclerosis stalwart Copaxone gets FDA boxed warning for anaphylaxis risk
After years of legal wrangling surrounding Teva’s Copaxone, the latest hit to the lucrative multiple sclerosis drug comes in the form of a safety-related boxed warning. | More than 80 cases of treatment-associated anaphylaxis have been reported since 1996,
FDA Tacks Boxed Warning on Teva’s Copaxone, Other MS Drugs
The drugs’ active ingredient, glatiramer acetate, has been linked to more than 80 cases of anaphylaxis worldwide since December 1996 and six patient deaths.
FDA warns of serious allergic reactions with some multiple sclerosis drugs
The U.S. Food and Drug Administration on Wednesday warned about the risk of a rare but serious allergic reaction with the use of some multiple sclerosis drugs including Teva's Copaxone.
FDA adds boxed warning to multiple sclerosis drugs after anaphylaxis cases
Teva Pharmaceutical’s Copaxone was approved by the FDA in 1996 to treat relapsing forms of MS, an autoimmune disorder that affects the central nervous system. Glatopa, a generic version of Teva’s product, was approved by the FDA this year and marketed by Sandoz. The drugs have demonstrated a 34% drop in the number of relapses compared to placebo.
FDA adds boxed warning to Teva’s Copaxone for allergic reaction
The Food and Drug Administration is adding a boxed warning about the risk of an allergic reaction for Teva‘s (TEVA) Copaxone and Sandoz’s
FDA Adds Boxed Warning to MS Drug Copaxone
Regulatory officials have identified 82 cases worldwide from the FDA Adverse Event Reporting System of anaphylaxis associated with the use of Coxapone and the generic Glatopa that have resulted in hospitalization or death.
FDA warns of rare but serious allergic reaction with glatiramer
The US Food and Drug Administration (FDA) is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (marketed under trade names including Copaxone, Glatopa),
FDA issues warning on anaphylaxis risk with MS drugs
The FDA has added a boxed warning, its most serious designation, to Copaxone and Glatopa due to the risk of anaphylaxis, a rare but serious allergic reaction. This severe reaction can occur at any time during treatment, including months or years after starting the drug, according to a Jan. 22 news release from the agency.
FDA: Anaphylaxis Risk Prompts Boxed Warning for MS Drug
Reports of anaphylaxis associated with the use of glatiramer acetate have prompted the Food and Drug Administration (FDA) to add a Boxed Warning to the prescribing information.
FDA Warns of Severe Allergic Reactions With Certain Multiple Sclerosis Drugs
The FDA issued a boxed warning for anaphylaxis risk linked to Glatiramer acetate and Glatopa, used in MS treatment. Anaphylaxis symptoms can appear within an hour of injection and may lead to severe conditions,
pharmaphorum4d
Copaxone first on FDA's list for faster complex generic approvals
Mylan’s long-awaited rival for Teva’s blockbuster multiple sclerosis drug Copaxone has been approved in the US, putting a large chunk of the Israeli firm’s revenues at risk. The timing could ...
FDA warns of serious allergic reactions with multiple sclerosis drugs
The U.S. Food and Drug Administration on Wednesday warned about the risk of a rare but serious allergic reaction with the use ...