Copaxone Promotional Activities Misleading, FDA Warning Letter Says

In a recently issued warning letter, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) told Teva Neuroscience Inc. that promotional activities for Copaxone (glatiramer acetate injection) are misleading.

In a letter dated March 14, OPDP told Teva Neuroscience that professional exhibit panels and web pages for Copaxone are false or misleading because they overstate the drug’s efficacy, present unsubstantiated claims, broaden the drug’s indication, omit and minimize important risk information, and omit material facts.

Copaxone is indicated to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis (RRMS), including patients who have experienced a first ...