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Hi-Tech Pharmacal Co., Inc. Message Board

  • Hikeleader Hikeleader Jan 23, 2012 2:30 PM Flag

    Lodrane Update

    http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_E/threadview?m=tm&bn=99215&tid=131077&mid=131077&tof=1&rt=2&frt=2&off=1

    expected 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

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    • Another update on iHub ELTP board:

      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

      • 1 Reply to Hikeleader
      • To be candid, I am a little frustrated with ECR. A month ago, they say mid to late 2012. Not much more than a month later (if that much), they seem to be adding 6 months to a year plus.

        I realize that they are frustrated, but this is their job. Just because this was their bread and butter product, doesn't mean that they are entitled to it.

        About 9 month ago someone said that they had spoken to someone in "Congress" and they were going to fix it. That was outrageous. They should start doing their job.

        And remember this, we deserve the truth. We can handle the truth, but maybe they can't.

    • http://www.globenewswire.com/newsroom/news.html?d=233313 .......this is one the links to that info

    • I am confused - is the lodraine D capsules the product that hitk bought in August-September of last year, but did not expect it to be approved for about 6 months? And if so, why has there been no approval announced?

      Actually, if that is true, the info on the other lodraine products may actually be good news because I really didn't expect that they were going to approve it.

    • great post, thanks for the update

 
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