Has Lodrane 24 Been Discontinued And If So Why

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Has Lodrane 24 has been discontinued and if so, why?

28 Replies (2 Pages)

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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

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2

Hoamirror's reply: Thanks hike, thanks Ginny. This information is good to hear from you, Ginny. I will be waiting and looking for Lodrane 24's comeback. It works better than any over the counter allergy med that I have ever taken. Thanks hike for your fast reply. Nobody I've asked about Lodrane 24's disappearance has known anything. Love to you both!!!

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There is also a post that someone made here:

https:/­/­rxchat.com/­Discuss/­Lodrane-D-is-now-being-produced-by-Elite-Pharmaceuticals-223098.htm

That has the press release about it being back in production.


Since it contains Pseudoephedrine, it will have to be purchased from your pharmacy, which will require your showing identification and signing for the purchase.


https:/­/­rxchat.com/­wiki/­Pseudoephedrine/­

Are there any other comments or questions?

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4

I've had the same problem finding Lodrane 24D in the past 6 months. Recently I found out that my pharmacy had the 12D but now my bc/bs insurance will not cover it. I was pretty upset to pay the $48+ for a month's pills but I need this prescription to help me survive during the spring months. I am highly allergic to almost everything and have to take allergy shots, singular and use nasonex. If I don't take my meds I get sick and it takes months of antibotics and shots to get me over it. For me Lodrane D is a life saver. I will be glad to see it back on the shelves soon!

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5

Lodrane 24 has been the only product that both my husband and I can take without the jitters, heart palpitations and all the good stuff. I keep looking forward to when I can again get Lodrane 24 even if with a script.

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6

It's a frustrating work-around, but you can purchase Chlor-Trimeton 4 hour tablets over the counter now. They contain the same active ingredient. It's the only thing that has finally helped me get in control. I'm really annoyed I can't have a 24 hour pill any longer and that it's not covered by my insurance since obviously it's over the counter. But, taking this every 4 hours sure beats the alternatives!

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7

Chlor-trimeton also has a 12 hour version plus a generic found it (the 12 hour) at CVS, but they seem to go quick since only 1 box of 24 was available so my husband and I split 1/2 & 1/2 so at least we are good for 6 days.

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8

Hi, I loved Lodrane 24 !! It is the only drug that worked great for me, I am very upset that the FDA stopped the sale of this product. I would be the happiest man on the planet If Lodrane 24 was able to be Avalible again !! I absolutely loved it !! Any chance of it making a comeback ? I sure hope so. Please give us an update as of 3-18-12. Thank you, Mike

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9

Well I was having these bad migraine headaches. I finally went to urgent care and the MD gave me samples of the lodrane D and it worked wonderfully...I cannot find any other medicine that works like that....apparently the allergies were causing my migraines...however I have never had trouble with allergies before so it was a first for me....but please keep us up to date...suffering is not fun....

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10

Guys -- look at this. I went back to the other post referenced here. I think it's out!

ecrpharma.com/products/allergy.html

TussiCaps ?

webmd.com/drugs/drug-149202-TussiCaps+Oral.aspx?drugid=149202&drugname=TussiCaps+Oral

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11

I'm confused... Is Lodrane 24D still avaliable but under a different name? Or is there a very similar product on the market? I've just run out of my prescription, and was told when I went to get it refilled that it's not made anymore... Nothing else has worked for my allergies, so I've been having to get by with Claritin and Benedryl (which don't work anywhere close to as well!).

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12

Only Lodrane D immediate release that you have to take every 4-6 hours is currently availible. Its 4mg bromphenimine & 60 mg of sudafed & I had to get a Drs Rx. & Ins. would not cover it & its expensive. But I was told the long acting Lodranes are waiting approval by the FDA & should be out at the end of 2012 or early next year.

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13

This is the only one that has worked for me. I've been to 4 doctors and even the emergency room. I DON'T have allergies, but got sick in NC and couldn't shake it. Now I'm in TN under another Drs. care and he gave me a hand full of these. Unbelievable relief, I don't see how this many people use it and being sold for this long, that the FDA can just wave their wand and make it go away.

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14

No Doubt, Lodrane is the best antihistamine I have ever used. This new version is too expensive though, (Because you have to take every 4 hours) & Ins. Doesn't cover it, But they did cover the Lodrane W/O the decongestant. Can't wait till the FDA gives the new formula approval( Once a day version)

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15

Ummm, not really. Chlor-Trimeton's active is chlorpheniramine, and Lodrane's is brompheniramine.

I wish it were true, but I tried Chlor-Trimeton as soon as the Lodrane was yanked, and it did absolutely nothing for me personally.

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16

Yup, Not a replacement for Lodrane . Choriphenimine gives me a dry sore throat. Can't wait for Lodrane to come back !!!

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17

is there anyway the public can demand the FDA bring back our Lodrane 24? Some of us are really suffering in Tenn. This year has been one of the worst for allergy sufferers here.

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18

Lodraine d was prescribed for our then 9 year old grandson, and it was perhaps the first medication that did as they said. He could breathe, stopped sneezing, didn't feel "spacey" and wasn't sleepy either. Our granddaughter who is 14 (at the ok of her doctor) tried it one time for an intense allergy, which she needed to resolve in order to participate in a school activity without sneezing or feeling fatigued. Her other allergy medications including Cetirizine, Clarinex, Claritin, etc.never fully work to clear the congestion nor stop the sneezing...EVER. The Lodrane completely cleared her up. Not only did it work quickly, STOP her sneezing, clear the congestion and not make her sleeply nor leave her feeling listless and drug out; however, it lasted over 48 hours before she needed the second dose. It seems if a medication works that it is then deemed as needing to be pulled from the market, allowing the other medications to take our money without ever really working. If abuse is the reasoning then they need to realize that ANY medication can be abused including Asperin. You don't need to be a rocket scientest nor a brain surgeon to realize that you cannot save a person from himself. If the ingredient in the prescription (in the amount that it is prescribed) is dangerous, then we fully back these being pulled from the market; but, if any medication that is safe if taken as prescribed is removed then shame on the FDA or other powers to be. I think it all falls down to who pays whom off first (or perhaps the most) or ...do I hear a type of blackmail ??? happening??? Either way, We are the ones to suffer. Bottom line...if the ingredients in Lodrane D are safe as prescribed than they need to be placed back on the market in the same form as they were originally marketed. And we don't mean change this or that to look good thus ruining the properties that actually work. It works.

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19

I used to get my prescriptions through Express Scripts and for those that do, E. S. would offer free OTC stuff in lieu of prescription stuff. Worked for me.

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20

Let's get to the nitty gritty of the reason why these drugs were included in the notice. The drugs that are in this medicine were independently approved by the FDA. I could purchase all of these drugs and combine them myself. Then the company started combining them. The FDA said, WHOA, this is a NEW drug, so you have to go back through the whole process, as if its a brand new drug just going on the market: BULLS***, it was another way the dictator's administration is getting money out of companies now, because the country is so broke. Now all of the R&D costs along with all of the other crap that goes with it has to be performed, along with its cost. So, no doubt the future price of the medication is going to go up once they have passed FDA approval. Thanks to all of the idiots who vote for you king, I sincerely hope that YOUR insurance plans do NOT pay for the medications and you have to pay every dime out of pocket, you deserve it and a whole lot more. BTW, for this who actually work and voted for him, how did you like those new taxes you got hit with 1/1/13. The bad thing is, the good people suffer (too) by the decisions of fools.

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28

Ms. Perrin, I've talked with you several times at ECR. Can't get you since 2012. I've called the FDA about 4 times in the past plus recently. No answers. no record of med. I'm in my 80's and would love to be able to smell and taste again. No luck with any other antihistamine. That includes Allegra 24D. Lodrane 24D was the only med. that works. My M.D. had me take 2 every a.m. If anyone tweets, please ask Pres. Trump to help us.

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27

Has Lodrane 24D been returned to market? Does Ginny Perrin of ECR Pharm have any current info.?

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26

It would be wonderful to be able to taste and smell again. I've been waiting for years for lodrane 24D to be available again. My M.D. and I have tried to find a substitute, but nothing tried works. I've called the FDA 4 or 5 times, but no answers to my question. My allergies are perennial and it isn't safe to take prednisone so often or at high doses. Can anyone help to have the FDA get this med. back on the market?

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25

Elite Pharma took over production of Lodrane from ECR.

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24

Verwon,
YOU, my friend, are a lifesaver. Thanks for posting that follow-up link about Lodrane-D. It is the ONLY thing that works for me. I was about to have a tizzy thinking they quit producing it. Thank you!

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23

Hell!!! I miss Drixoral. The Dumb A** bureaucratic IDIOTS that must protect us innocent tax payer "drones" are the problem. Too much nanny state from BHO and his minions/zombies. The problems started with Bush and BHO put the deal on steroids. They need to get out off our lives and become real protectors of America.

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22

I have really missed the whole Lodrane medication. My son has DS and can not swallow pills. I could take the Lodrane capsules apart and he would swallow them WITHOUT chewing them. He got the whole benefit from the pill and now I can't find anything that is comparable. Much to my dismay!

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21

Does anyone have a current vendor for brompheniramine (whether lordrane or lo-hist or anything else)?

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