Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

We need projected revenues for Isradipine for 1/2 million Parkinson patients.

It's a little more complicated than that. Elite could file a Prior Approval Supplement to their isradipine ANDA and get FDA approval to market the drug for the new indication (P.D.) with a new brand name (and presumably new price). Theoretically, they could market a brand name version for P.D. and continue to sell generic isradipine, too. Docs would prescribe the brand if there was a good reason, such as a first month "Starter Pack," which would be a bubble pack that uses 2.5mg tablets to titrate up the dose over 4 weeks to the study dose of 5mg 2x/day. Since isradipine is a strong BP drug, they used a ramp-up dosing regimen like this in the STEADY-PDIII trial and achieved excellent participant retention. Not only could they charge more for a brand name starter pack, it would actually be a cool thing that would be helpful and increase safety. I would think the FDA would be receptive to that kind of marketing proposal.







https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm077097.pdf

Guidance for Industry
Changes to an Approved NDA or ANDA


B. Major Changes (Prior Approval Supplement)

1. Changes based on postmarketing study results, including, but not limited to, labeling changes associated with new indications and usage.