Generic Copaxone Approved for Multiple Sclerosis
Autoimmune disease affects central nervous system
THURSDAY, April 16, 2015 (HealthDay News) -- The first U.S. generic version of Copaxone (glatiramer acetate injection) has been approved by the Food and Drug Administration to treat multiple sclerosis (MS).
The brand-name drug is produced by Israel-based Teva Pharmaceuticals. It's approved to treat MS, a chronic central nervous system disease caused by an overly aggressive immune system that turns on the body itself. Typical symptoms include muscle weakness, coordination problems and disability. First symptoms usually begin between ages 20 and 40.
License to produce the generic equivalent of Copaxone was issued to the Swiss-based drugmaker Sandoz, the FDA said Thursday in a news release.
The most common side effects of Copaxone include injection-site redness and pain, flushing, rash, shortness of breath and chest pain.
The FDA issued a reminder that generic medications are chemically equivalent to brand-name drugs, and that the agency applies the same rigorous manufacturing standards to both.
The FDA has more.