Elite Pharmaceuticals Inc (ELTP): The question becomes if that’s an issue...

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Elite Pharmaceuticals Inc (ELTP)

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Re: jour_trader post# 334777

Saturday, 06/06/2020 8:55:29 PM

Saturday, June 06, 2020 8:55:29 PM

The question becomes if that’s an issue for Elite and raises the amount they owe to the FDA, that they were trying to avoid (~$2M).

In regards to annual GDUFA fees, a medium-sized pharma has between 6-19 approved ANDA. I count 13 unique active ANDA listed in the FDA Orange Book for Elite Labs, and there are also 3 discontinued ANDA. The ANDA's cover the 11 drugs listed on the Elite website products page (link below). The reason there are 13 ANDA and only 11 drug products is because Elite has 4 active ANDA for phentermine but lists only 2 current phentermine products. (Interestingly, the 3 ANDA listed as discontinued are also for phentermine.)

https://www.elitepharma.com/products/

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