Elite Pharmaceuticals Inc (ELTP)

[Hike]

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expexted mid to late 2012.
Regarding Lodrane 24 and Lodrane 24D availability: March 2, 2011 the FDA
published a notice that some 500 cough/cold/allergy products were to cease
manufacturer distribution on August 31, 2011. Our three Lodrane products
(Lodrane 24, Lodrane 24D, and Lodrane 12D) were included in this notice.
This notice was not a product recall and there were no safety issues with
our products. We now have an immediate-release, over-the-counter product
available, Lodrane D Capsules. I've attached product labeling for Lodrane D
Capsules. Lodrane D Capsules contain the same antihistamine
(brompheniramine) and the same decongestant (pseudoephedrine) that were in
Lodrane 12D and Lodrane 24D (Lodrane 24 did not contain a decongestant). The
FDA classifies Lodrane D Capsules as over-the-counter but many states and
pharmacy chains require a prescription because it contains pseudoephedrine.

More Background on Lodrane 12D, Lodrane 24, and Lodrane 24D: The FDA has
required additional work to fully approve these products as these Lodranes
were extended-release formulations and though these have been long marketed
(some similar products have been marketed for more than 30 years) a 1964
regulation classifies extended-release products as new products and hence
require a full NDA. We began the work in 2010 but the 180 day notice did not
allow the work to be completed by August 31. We continue to complete the
requirements and hope to be able to return these Lodrane products to the
market by mid-late 2012. We very much regret this occurrence and certainly
understand the negative effect this has. We also regret that no similar
product is currently available, a plea that we made to FDA. We wish we had
better news but the FDA action has resulted in a number of very beneficial
products being unavailable to physicians and their patients.

Thank you for your interest in ECR Pharmaceuticals,
Ginny Perrin