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Copaxone News
FDA Medwatch Alert: Drug Safety Communication: Copaxone, Glatopa (glatiramer acetate) - FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis
ISSUE: The FDA is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used to treat patients with multiple sclerosis...
FDA Medwatch Alert: Cross-Compatibility Issues with Autoinjector Devices Optional for Use with Glatiramer Acetate Injection
May 16, 2024 – FDA is alerting patients, caregivers, and health care professionals of labeling updates for glatiramer acetate injection products. Updated labeling includes a new warning that using...
FDA Medwatch Alert: FDA Alerts Patients, Caregivers, and Health Care Providers of Cross-Compatibility Issues with Autoinjector Devices That Are Optional for Use with Glatiramer Acetate Injection
August 18, 2022 – FDA is alerting patients, caregivers, and health care professionals that autoinjector devices that are optional for use with glatiramer acetate injection may not be compatible for...
FDA Approves Glatopa (glatiramer acetate) as the First Generic Competitor to Copaxone
Holzkirchen, Germany, April 16, 2015 - Sandoz, a Novartis company, today announced the US approval of Glatopa, the first generic version of Teva's Copaxone (glatiramer acetate injection) 20 mg/ml...
Teva Announces U.S. FDA Approval of Three-Times-a-Week Copaxone (glatiramer acetate injection) 40mg/mL
JERUSALEM--(BUSINESS WIRE)--Jan. 28, 2014-- Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental new drug a...