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US FDA nod for storing Copaxone pre-filled syringe up to 1 month at room temperature
Paris, France | Wednesday, June 20, 2007, 08:00 Hrs  [IST]

Teva Pharmaceutical Industries, and sanofi-aventis announced that the application for up to one month room temperature storage of Copaxone (glatiramer acetate injection) pre-filled syringe has been approved by the US Food and Drug Administration (FDA) and in Europe under the Mutual Recognition Procedure (MRP). With this supplemental amendment, Copaxone may now be stored by patients at room temperature for up to one month.

Prior to this approval, Copaxone was approved for storage at room temperature for up to seven days. Christina A, Germany, an opera singer who has been using Copaxone for the past six years commented, "As a performer, I spend a lot of time on tour. Transporting and storing my copaxone will now be much easier".

"For the past fifteen years, Copaxone has allowed me to control my disease and has granted me the ability to maintain an active lifestyle," said Laura K., a participant in the first pivotal trial evaluating the drug. "As a competitive equestrian, I spend a lot of time away from home, and now that Copaxone can remain at room temperature for a longer period of time, transporting and storing it will be much easier."

Copaxone is indicated for the reduction of the frequency of relapses in ambulatory patients with RRMS characterized by at least two attacks of neurological dysfunction over the preceding two-year period.

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