Elite Pharmaceuticals Inc (ELTP)

[The ELTP King]

WeeZuhl: "It didn't benefit Lannett very much to put the ANDA on the discontinued list. They can still activate the ANDA when they choose, but they will have to go through a substantial, costly, time-consuming process which is not much different than getting the approval in the first place. They would need to redo all the API certifications and commercial batches and then get a re-approval from FDA. They would not have discontinued it if they had any intention of commercializing it any time in the near future (several years for sure)."

The processing of changing the status isn't a big deal. They submit a request, get asked to fill out a form, FDA sees it, decides it makes sense, and boom drugs are active again when marketing starts.

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