Posted from: Wednesday, April 29, 2015 - 11:21 AM - Present

First Generic to Copaxone Approved

April 16, 2015 – The U.S. Food and Drug Administration (FDA) approved Glatopa (glatiramer acetate injection) 20mg/mL, an A-rated generic equivalent to Teva’s Copaxone 20mg/mL. Glatopa is manufactured by Sandoz. Copaxone and is a disease-modifying drug that is indicated to treat patients with relapsing forms of multiple sclerosis. Copaxone 20mg/mL is administered as a daily subcutaneous (SC) injection. Launch plans for Glatopa are uncertain at this time.

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.

Actual drug patent expiration dates and a 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.

 

Last Updated Monday, May 22, 2017 - 11:18 AM.