Elite Pharmaceuticals Inc (ELTP)

[KravMD]

I contacted ECR last week regarding Lodrane 24D and it's reintroduction into the marketplace. Here is the response I received:

Hello,
Regarding Lodrane 24D availability: The FDA has required additional work to
fully approve these products as the 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 and we continue to complete the requirements.  We had
hoped to be able to return the Lodrane products to the market by mid-late
2012, however, due to the very slow and lengthy process of FDA review we are
unable to provide a definite timeframe when approval may be granted.  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.


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.

Thank you for your interest in ECR Pharmaceuticals and your patience,
Ginny Perrin