FDA Approves Higher/Less Frequent Doses of Teva's Copaxone as Generics Hover

Jan 30, 2014


Teva Pharmaceutical Industries was granted U.S. FDA approval for a longer-acting version of its Copaxone multiple-sclerosis drug, helping the company’s effort to defend its top-selling product as competitors introduce generic versions this coming May.

Teva can now offer Copaxone for use as a 40-milligram shot three times a week, as an option to the 20-milligram daily injection approved in 1996. This new dosage reduces the number of injections by 60 percent.

According to Teva, it will seek to move as many as half of the patients taking daily Copaxone injections to the newer version, which would have patent protection until 2030.

Read the Bloomberg press release