New Generic for Copaxone Approved
February 13, 2018 – The U.S. FDA has approved Sandoz and Momenta Pharmaceutical’s Glatopa® (glatiramer acetate) 40mg/mL injection, a generic to Teva’s Copaxone® (glatiramer acetate) 40mg/mL injection. It is the latest in a series of Copaxone generics approved over the last two years.
Sandoz previously received FDA approval for its 20mg/mL generic for Copaxone in June of 2015. Competitor Mylan has held FDA approval for its own generic to Copaxone 40mg/mL since October of 2017.
Glatiramer acetate is indicated to treat patients who have relapsing forms of multiple sclerosis, and is administered via injection three times per week in its 40mg/mL dosage form. Recommended dosing for the 20mg/mL dosage form is once per day. In clinical studies, glatiramer acetate has been shown to reduce the number of relapses that patients experience, as well as the number of brain lesions.
Sandoz has announced a $0 copay program for eligible patients, and will provide additional support to all patients through a free starter kit, available injection training, and 24-hour access to nurses who can answer questions about Glatopa. The product has already been launched.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.