The market is full of drugs that are combinations of OTC medications and usually they are way more expensive. Even if they didn't go nuts with the price, why make a patient pay $0.50 per pill when they could take 2 for $0.04?
As to the question about why it is taking so long at the FDA, I imagine it isn't a very high priority because there are alternatives.
The problem is the lack of transparency into cost which results in some drug companies taking advantage.
Combine two pills that cost $0.10 each into one pill that costs $0.15? Reasonable.
Do the same and charge $5 per pill? Ridiculous. Problem is doctors and patients don’t know it costs $5 and insurers can’t be bothered to push back. Suddenly you’ve increased the cost of therapy by 50x.
The FDA has a massive backlog for generic drugs, while novel drugs (NDA) don’t.
What's the point of this, compared to just having half a pill of tylenol and half a pill of ibuprofen?
Meanwhile 500mg is, I believe, more than they combine with opiates and acetaminophen does lead to death via organ failure on the order of hundreds of people a year. I was curious why they weighted the acetaminophen proportionally so much higher than the ibuprofen.
Unless they need to be prescribed in ratios that can't be achieved reasonably with the cheap OTC pill dose sizes, it's not clear to my why I'd want a combined bill instead of just taking separate pills.
Taking more than one pill is less convenient, but except for people who have trouble with pills in general I doubt they would want to pay more for that convenience.
Even in the case of fairly high doses, it is not too bad. A few months ago, for example, I somehow managed to get a painful rotator cuff injury while sleeping (no idea how), and my doctor told me to take 1000 mg Tylenol every 8 hours and 800 mg of ibuprofen every 8 hours. At the most common OTC strengths, that would be two Tylenol pills and 4 ibuprofen pills.
It's a damn shame that doctors often fail to tell people about cheaper and more irritating alternatives, but there's nothing wrong with giving people the option to pay more for a better experience.
You often see this in terms of number of times a drug had to be taken per day. There'll be a generic that needs to be taken say three times a day, and a newer drug that only needs to be taken once.
I highly doubt every manufacturer of Ibuprofen or Acetaminophen would decide to throw in the towel if this new drug was released.
The drugs in question could, combined have deleterious effects (say if their extortion mechanisms are the same).
This shouldn’t be a problem because Tylenol + Advil has been done for decades. However, a beauricracy doesn’t see it as a solved problem to fast track unless there is a specific fast track for this exact scenario.
I was at a continuing education course last year. FDA approved a new narcotic very fast. A non narcotic alternative is taking forever to approve.
Its name is Maxigesic. Tylenol and ibuprofen in one pill.
Why?