FT.com
FDA request slows launch of cheap Prilosec By Christopher Bowe in New York Published: October 29 2002 21:38 A potential cheap version of Prilosec, the blockbuster heartburn medicine, is to be delayed after Procter & Gamble said it did not expect US regulatory approval of its over-the-counter product until late next year.

Postponement of the final approval stems from the US Food and Drug Administration's request for a study to make sure consumers understood that the treatment was long-acting and once-per-day. That study will take eight more weeks and six months for regulatory review. The FDA has otherwise tentatively approved P&G's retail version.

This is bad news, good news and bad news for me. For someone who takes Prilosec every day, it's bad news that an over-the-counter version is delayed. It's good news because I didn't know an over-the-counter version was even on its way. It's bad news because I live in Japan and it will probably take another Admiral Perry to get it approved in Japan.

For those of you who don't know what Prilosec is... It is the best medicine for chronic heartburn that I know of. I used to have heartburn every day and ulcers. I took all kinds of anti-acid medication and it never worked. After I started taking Prilosec I'm completely fine. I spent SOO much of my high school and college years fighting with my aching stomach that discovering Prilosec was really a key moment in my life. A US doctor recommended it and I had my doctor in Japan search down an equivalent and prescribe it to me.

6 Comments

"I had my doctor in Japan search down an equivalent" ... which is what?

Wouldn't an over-the-counter version cost more in Japan, where you only pay 20-30% of the price of prescription drugs? How much is over-the-counter Gastor compared to prescription Gastor?

The Japanese version is Omepral. Unfortunatey, I don't know what Gastor is... I think the point of the P&G over-the-counter version was that it was cheaper. That's a good point tho. In Japan, it might end up being more.

I've been following this story too. I've had reflux since the mid 90s and I took Prilosec for years (I'm currently taking a high dose of Prevacid, which my body seems to tolerate better, the Prilosec was giving me tintinitus, which went away when I switched..)

But availability of a generic proton-pump inhibitor will be good for everyone who has to take them because it will put downward pressure on prices..hopefully..

:)

Lets hope that they dont find another reason to delay it. There's lots of big money interests trying to keep these extremely useful drugs expensive..

Hey! I'm a refluxer too! I never go anywhere without my Prevacid stash.

Right on, Howard.. *laugh* So do I...

hey, then here is something I should definitely share..

An interesting discovery.. and good to know in a pinch.. Ginger seems to reduce reflux.. I noticed this a few weeks ago when I ate a bunch of crystallized ginger candy... That night, my reflux was *much* reduced..

I've been able to repeat this a few times since then..so I am pretty sure it was the ginger and not anything else..

did you no you are a google whack????

tintinitus and loaf!!!!!!

laura x

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