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FDA adds boxed warning to multiple sclerosis drugs
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 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 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,
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 issues warning on anaphylaxis risk with MS drugs
Symptoms of anaphylaxis typically develop within an hour of injection and can include wheezing, difficulty breathing, swelling of the face or throat and hives. In some cases, the reaction can lead to hospitalization or death.
SCOTUSblog
2d
Menthol vapes and forum shopping, FDA tobacco control comes before justices
The Supreme Court will hear oral arguments on Tuesday in a clash over whether a North Carolina-based company can challenge the Food and Drug Administration’s denial of its application to market ...
2d
on MSN
Supreme Court seems skeptical of court-shopping claim against vape makers
The FDA says vaping companies are improperly gaming the court system, filing claims in an appeals court they think will be sympathetic to them.
Hosted on MSN
6d
FDA beats EMA to most approved new drugs in 2024
On 15 January, the two agencies released respective lists of medicines approved last year. The FDA approved 50 novel drugs ...
healthday
6d
FDA Approves Marketing of Nicotine Pouches
Following an extensive scientific review, the U.S. Food and Drug Administration has authorized the marketing of 20 ZYN ...
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