Synthon Submits ANDA for Glatiramer Acetate Dossier
Synthon has submitted an Abbreviated New Drug Application for Glatiramer acetate, 20 mg/ml solution for injection in pre-filled syringes to the FDA.
Synthon announced Tuesday that it has recently submitted an Abbreviated New Drug Application (ANDA) for Glatiramer acetate, 20 mg/ml solution for injection in pre-filled syringes to the FDA.
This is an important milestone for Synthon towards introduction of a generic version of this multiple sclerosis (MS) drug on the US market.
The reference listed drug for Glatiramer acetate is Copaxone, indicated for reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis (RRMS). Copaxone sales in the US are expected to reach $2.4 billion in 2011.
Synthon’s CEO Rudy Mareel stated: “The avail
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