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Elite Pharmaceuticals seeks US FDA approval for generic nervous system drug

Elite Pharmaceuticals Inc. filed an abbreviated new drug application with the U.S. Food and Drug Administration for a generic version of an extended-release central nervous system stimulant.

The New Jersey-based pharmaceutical company said the product is co-developed with SunGen Pharma LLC under a development and license agreement.

Under the agreement, the companies jointly own the product, and Elite will have the exclusive right to market and sell the product using its label. Elite will also manufacture and package the product on a cost-plus basis.

The branded products of the extended-release drug had total U.S. sales of $1.6 billion for the 12-months ended Sept. 30, 2017.

Previously, the companies filed for an abbreviated new drug application for an immediate-release central nervous system stimulant.

SunGen Pharma is a privately held specialty pharmaceutical company that develops, contract manufactures and sells pharmaceutical finished products.