Elite Pharmaceuticals Inc (ELTP): soccadoc Elite is currently doing the...

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Elite Pharmaceuticals Inc (ELTP)

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Re: soccadoc post# 26513

Saturday, 09/15/2012 10:53:35 AM

Saturday, September 15, 2012 10:53:35 AM

soccadoc

Elite is currently doing the R&D for ECR on the CR Lodrane 24D which will be for a NDA approval.

It is very unlikely that Elite would be legally allowed to undertake the R&D for a potential competitor "Lodrane" product.

The original Lodrane® 12D and 24D were discontinued by the FDA not because of the active ingredients brompheniramine maleate and pseudoephedrine hydrochloride. The products were discontinued because of Elite's CR polymer, for the 12Hr and 24Hr, that had never been FDA clinically tested to be reliable against body fluids and therefore not cause dose dumping.

IMO the new Elite/ECR Lodrane 24D will likely be tested as an ELI-154 NDA 505b2.

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