Generic to Copaxone Launched
June 18, 2015 - Sandoz and Momenta announced the launch of Glatopa™, an A-rated generic to Teva’s Copaxone® (glatiramer acetate 20mg/mL). Glatopa is available in a single-dose prefilled syringe with a white plunger.
Copaxone is approved for the treatment of patients with relapsing forms of multiple sclerosis (MS). This formulation is administered as a once-daily subcutaneous (SC) injection. Glatopa is currently the only FDA-approved generic to Copaxone, but it was not awarded exclusivity. According to IMS Health, annual U.S. sales of Glatopa were $2.4 billion in 2014.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.