Elite Pharmaceuticals Inc (ELTP)

[RizZo]

SunGen Pharma and Elite Pharmaceuticals file an ANDA with the FDA


2019-09-07



This is the second ANDA filed by both the companies, giving Elite Pharmaceutical the exclusive right to retail the drug.

Elite Pharmaceuticals, Inc. a pharmaceutical company that creates niche generic products and abuse-deterrent opioids, recently announced that it has submitted an ANDA (Abbreviated New Drug Application) with the U.S. Food and Drug Administration (FDA) for a standard version of an extended-release CNS stimulant.

According to sources, the ANDA signifies the filing of a second drug co-developed with SunGen Pharma LLC. Earlier, SunGen and Elite had submitted an ANDA to a standard version of an immediate-release CNS stimulant. As per a report published by QuintilesIMS Health, the proprietary product for the extended-release, CNS stimulant and its counterparts recorded a total sale of $1.6 billion within twelve months in the U.S.

Reportedly, as per the terms of the deal, the product would be jointly owned by SunGen and Elite. Moreover, Elite would have the sole right to market and retail the product under its label as well as would package and manufacture the product on a cost-plus basis.

Speaking on the move, Nasrat Hakim, President and CEO, Elite, said that this is the second ANDA within the last three months, created and filed with SunGen, and the firm is looking forward to filing more ANDAs in the future. Hakim claims that, with the addition of their SequestOx™ NDA filing, the company has a sum of six ANDAs under the FDA’s review.

As for Dr. Jim Huang, Co-CEO, SunGen, the company is delighted to file another ANDA with the FDA through its collaboration with Elite, as they proceed with the co-development of additional ANDAs.

For the uninitiated, SunGen Pharma is a therapeutic company that develops, produces and retails finished pharmaceutical products. It specializes in the advancement of complex injectable products and oral solid extended release. Additionally, it is collaborating with various U.S.-based generic pharmaceutical firms to develop, retail and produce several medicinal products in the states.













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