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Generic "Valtrex" on the Immediate Horizon

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Mylan on the Generic Attack

It was a busy day for generic drugmaker Mylan Laboratories (NYSE: MYL), which announced four separate news releases today. First came news of a management shakeup in conjunction with its acquisition of Indian generic drugmaker Matrix Laboratories. Mylan followed that up with two more approvals -- one to market a generic version of GlaxoSmithKline's (NYSE: GSK) antiviral herpes treatment Valtrex, and another to market a generic version of Alza's Duragesic pain patch. (Alza is a subsidiary of Johnson & Johnson (NYSE: JNJ).)

But it is the news that a piece of legislation was introduced in the Senate yesterday that might have the biggest effect on Mylan and competitors like Barr Pharmaceuticals (NYSE: BRL), and the future of the generic-drug industry as a whole. This legislation would outlaw the practice of pharmaceutical companies launching authorized generic versions of their branded drugs.

for the rest...


Tentative FDA Approval for Teva Pharmaceutical's Generic Valtrex

Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) announced that it has received tentative approve for its generic version of Valtrex.

Manufactured by GlaxoKleinSmith, the patent for Valtrex expires in December and final approval for the generic version is expected at that time. Mylan Laboratories Inc. (NYSE:MYL) has also received tentative FDA approval for generic Valtrex. Valtrex is used in the treatment of herpes zoster (shingles), genital herpes and herpes labialis (cold sores).

Total sales of Valtrex were about $1.3 billion last year.


*note: the Valtrex patent expires in June 2009, not December of 2008. I believe that got an extension or that this article is incorrect.

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Doubt it'll be on the Walmart $4 list anytime soon. Those generic 200mg Acyclovir capsules due just as good a job as Valtrex.

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    • BioHacker
      Meds and condoms is really all you need. Statistically, HSV2 is so widespread because 80-90% of  people who have it are unaware that they have it, and so they don't take all recommended precautions (including using condoms). Oddly enough, if you were to replace your HSV2+ girlfriend (aware of HSV status, using condoms, using suppressive meds) with the average American woman (unaware of HSV status, but 25% risk, which is average - and using condoms at all times, since presumably you could insist on it), you would actually NOT reduce your risk of HSV2. The statistical risk would be approximately the same for both theoretical girlfriends (about 0.7% per year assuming sex 2x per week). That is a bit simplistic, because maybe you could decide to date only women who are verified virgins (essentially no risk), or maybe "below average risk" in some way (younger than average, fewer prior partners than average, etc.), or you could have all prospective girlfriends IgG blood tested for HSV as a condition to dating them (or having sex with them), which would reduce the risk significantly (especially if you confirmed the paperwork), but not completely (since antibodies take some time to develop). At some point, beyond-standard precautions become inconvenient and not worth the hassle (or risk of being perceived as paranoid). The risk isn't zero, and probably would never be zero, short of taking extreme measures. Efforts to reduce risk beyond standard practices, which already reduce risk to relatively low levels, are naturally subject to the law of diminishing returns. Accepting some level of risk is (unfortunately) part of the deal in most reasonable endeavors. Also, there is statistically a greater likelihood of two people passing HPV between them one way or the other, than HSV2 (assuming all recommended precautions are being taken). Of course, you could get the HPV vaccine (everyone should!). But the vaccine only covers 10-15% of the types of HPV that are out there. And tests for HPV are imperfect, and generally not available for males. And HPV (some types) can cause cancer (cervical, penile, and throat - maybe others). So, keep that in mind as well. And then, of course, there are all the other risks . . . Best not to be paranoid though . . .
    • WilsoInAus
      That’s correct. HIV is a distinct virus. No virus morphs into another one.
    • WilsoInAus
      Hey @thebrightsidegirl I hope you’re going ok, I’ve read your posts and will see if I can draw some threads. I see that you have genital HSV-1 and your partner has oral HSV-1. I’m not sure if he has tested but given it’s somcommon there’s no reason to disbelieve that’s what he has. This is the best concirdant scenario you can hope for in a sexual relationship. You both already have the virus and your immune systems are established and your experience with herpes is your own. You cannot induce an outbreak in each other by virtue your own HSV-1 and transmission to a new location on your partner is too small to worry about. If HSV-2 is present, then it needs to be brought to the relationship. It’s not at all likely you have it given you were infected genitally with HSV-1.  I suggest these symptoms are very unlikely to be related to herpes at all. If they are, then it’s far more likely to be a recurrent outbreak issue with your HSV-1 as opposed to an initial infection with HSV-2. 
    • hopeing
      Ozone is basically toxic to humans at high levels. Its probably as likely to kill your cells as the virus. Add to that the virus is not in the blood and I'd say this 'treatment' is probably totally ineffective and if it does include high levels of real ozone likely dangerous. https://en.wikipedia.org/wiki/Ozone_therapy
    • thebrightsidegirl
      Hey Wilson , do you kids answering this , i was kind of worried too ? 
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