Italian Hair Loss Lotion To Hit The Market In 2016

paxis

paxis

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shookwun said:
i need hair pls
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I'd give you more hair than a gorilla could grow, but I am just a squirrel in a tuxedo.

Only Master Brotzus' potion can save us now.

hairblues said:
that would be too easy
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Exactly what i thought.. He would have nothing to complain. And thats unacceptable.
I don't even know why I am still bothered by these posts. I can't help it, it's just too stupid.
 
Blackber

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Barbe a papa said:
I was hoping maybe Fidia was dealing with the US regulations for over the counter drugs while the trials were happening, but I'm reading that the OTC review process is made public and someone would have heard about it if it was happening. As I read more about OTC though I'm realizing that it doesn't seem to meet the hair growth & hair loss drug monograph requirements. So I don't think it will be available from a US vendor in any capacity for a very long time. I may be misinterpreting it however and I welcome correction. It's possible that they're referring to claiming that a specific active ingredient is the one causing the hair growth. Whereas technically none of the lotion ingredients individually cause hair growth. So maybe there's a workaround, but I don't know.

After rereading European regulations, I'm very convinced there will be no problems with it releasing as a cosmetic in Europe in a timely manner. I'm just not looking forward to the potential hassles of ordering from the US. Hopefully it won't take an official vendor a long time after release to set up overseas shipment. I really don't want to buy from some sketchlord on ebay.

Sources:
USA regulations: http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm Keywords: "hair growth", "OTC"
USA OTC Hair growth/hair loss monograph: http://wayback.archive-it.org/7993/...OTCDrugs/StatusofOTCRulemakings/ucm094398.pdf

European Regulations: http://ec.europa.eu/consumers/sectors/cosmetics/files/Doctor/manual_borderlines_ol_en.pdf Keywords: "3.3.4"
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Nice post man. Need more of this around here.

I always felt it was going to take awhile to see this on shelves in the US, but I'm sure we'll figure it out.
 
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Xaser94

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This was taken from the link @Barbe a papa posted above mentioning fda rules.

"Drugs, however, must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-Counter (OTC) Drug Review. These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded.

FDA has published monographs, or rules, for a number of OTC drug categories. These monographs, which are published in the Federal Register, state requirements for categories of nonprescription drugs, such as what ingredients may be used and for what intended use. Among the many nonprescription drug categories covered by OTC monographs are
  • acne medications
  • treatments for dandruff, seborrheic dermatitis, and psoriasis
  • sunscreens"
So from what I understand, even if Brotzu's lotion is considered a drug, there is a way it can still be sold over the counter without FDA trials maybe.
 
Sokubo

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It's going to go through FDA trials, I don't think there is much of a way around that except in theory.
 
Pacey123

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Well i don't know how it's handled in the USA, but in Austria even Regaine (European counterpart of Rogaine) can't be sold in a regular shop, it's sold OTC yes, but only in drug stores (Apotheke), so I'm really sceptical if it's just a cosmetic, because so far, cosmetics didn't do sh*t for hairloss in Austria.

But then again, maybe there are loser regulations considering the ingredients in Italy and we will have it OTC in our drug stores.
 
resu

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Pacey123 said:
Well i don't know how it's handled in the USA, but in Austria even Regaine (European counterpart of Rogaine) can't be sold in a regular shop, it's sold OTC yes, but only in drug stores (Apotheke), so I'm really sceptical if it's just a cosmetic, because so far, cosmetics didn't do sh*t for hairloss in Austria.

But then again, maybe there are loser regulations considering the ingredients in Italy and we will have it OTC in our drug stores.
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Stemoxydine is also sold as a cosmetic. Regaine is only sold on drug stores and it costs a lot. If they sell it online they could cheapen the price and make the product availability much higher at least for Europeans, I doubt it will be available in the US since Stemox isn't either.
 
paxis

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I'd definetely help as much people as I can to receive the lotion somehow. Online WITH A TRACKING ID.

I'd kill myself if something is available that could save my hair, but I can't use cause of my countrys' regulations.

We are all in the same boat and I guess many europeans here would try to help.

Didn't beps say it will be availabe in canada really quick? How are the regulations there?
 
paxis

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resu said:
Stemoxydine is also sold as a cosmetic. Regaine is only sold on drug stores and it costs a lot. If they sell it online they could cheapen the price and make the product availability much higher at least for Europeans, I doubt it will be available in the US since Stemox isn't either.
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Wait, what? You can't buy regaine online? Where do you live? In germany at least you can order regaine and stemox everywhere online.
 
resu

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paxis said:
Wait, what? You can't buy regaine online? Where do you live? In germany at least you can order regaine and stemox everywhere online.
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I meant at physical stores, Regaine is only sold on pharmacies and in the US you can't find Stemox anywhere.
 
T

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I'm hoping that CETA will benefit this lotion
 
paxis

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spring15 said:
OK @paxis so you've nominated yourself as the official European distributor of brotion to the non-European brotioners? Much appreciated
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I am not the best candidate, cause I never send something to another country (or continent). I am rarely at the post office in general.

Maybe there is someone with more knowledge and experience. But I guess it shouldn't be a big problem shouldn't it? I mean if I don't understand something I can ask you guys or the post office.

I'd also discuss the price with you guys, I don't want to be a hustler. ;)

With my post I just wanted to say, that I would try my best to help anyone here. Hopefully I can.

But for now, we dont even know when it will be available in germany after it was released in italy and also if it actually works as promised or not.
 
T

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Pacey123 said:
I don't think that CETA or TTIP is going to change the import of drugs, but i hope for all of you that I'm wrong
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It means it would be more expensive if it isn't, but I shouldn't have any problem importing it, regardless.
 
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even if you go to Italy you will have to get the lotion back to whereever you live. Taking it through airports is basically the same as importing it, isn't it? If they will disallow it if they disallow it.
 
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