New Delhi, Oct 10 (UNI) Sun Pharmaceutical Industries Ltd today it has received final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to market its generic version of Novartis Trileptal, oxcarbazepine tablets.
These generic oxcarbazepine tablets are AB-rated equivalent of Novartis Trileptal tablets and include three strengths -- 150 mg, 300 mg and 600 mg. These strengths of Trileptal have annual sales of about 640 million dollars in the US.
The company expects to reach the market shortly with these products, a statement said.
Sun Pharma, being one of the first-to-file an ANDA for generic Trileptal with a para IV certification, shares a 180 day marketing exclusivity. No action for patent infringement has been brought against Sun Pharma.
Oxcarbazepinc is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures.