Elite Pharmaceuticals has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of an immediate release CNS stimulant.
The ANDA represents the first filing for a product co-developed with SunGen Pharma under their Development and License Agreement. According to IMS Health data the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ending September 30, 2017.
Under the terms of the Agreement, the product will be owned jointly by Elite and SunGen. Elite will have the exclusive right to market and sell the product using Elite’s label. Elite will also manufacture and package the product on a cost-plus basis.
“The filing of this ANDA represents the first of many products being developed under this Development and License Agreement with our partner, SunGen,” said Nasrat Hakim, president and chief executive officer of Elite.
“The strategic partnership with Elite is progressing exceedingly well,” said Dr. Jim Huang, co-chief executive officer of SunGen. “And we are very pleased with the filing of this first ANDA with more to follow.”