Sun Gets USFDA Nod For ‘Oxcarbazepine’ Tabs
Sun Pharmaceuticals has received final nod from the USFDA for its abbreviated new drug application (ANDA) to promote its generic version of oxcarbazepine tabs.
In a declaration, the company said that the generic oxcarbazepine tabs are AB-rated equivalent of Novartis Trileptal pills, and consist of three different potencies including 150 mg, 300 mg and 600 mg.
The yearly sales of Trileptal pills stood at around $640 million in the United States, the release added.
The release added, “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,”
Oxcarbazepine is suggested for use as monotherapy or adjunctive cure for treating partial seizures.
The Sun is likely to introduce the products in the US markets soon.