|2005P-0323||Immediately remove Adderall and Adderall XR from the market for safety reasons|
|FDA Comment Number :||EC3|
|Submitter :||Mr. Dave Lowe||Date & Time:||12/09/2005 10:12:11|
|Organization :||Mr. Dave Lowe|
|Category :||Individual Consumer|
| There is another petition on Adderall and reference that was originally submitted to he Division of Dockets Management on October 12th, 2005 (2005P-0420) also about Adderall XR. This is posted in light of more safety and efficicy issues of all Adderall products and may explain another petition.
That petitioner in the above petition notes Adderall is d- and l- amphetamine at a 3:1 ratio, and the extended release Adderall XR is a 50:50 ratio of mixed amphetamine salts in protocol 381.107. This would not be an extended release Adderall. The back of an Adderall XR drug ad confirms that data. FDA DDMAC has a complaint on Adderall XR as a marketed product and should have a copy which would show this.
The industry cannot just switch ratios, we have to be told as this is a new drug. In short, FDA cannot approve Adderall at 3:1 and allow this to continue. Adderall has no XR, XR has no Adderall and may explain the referenced petition seeking bioequivalency.
That is not extended release Adderall as the amphetamine salts are of a different ratio. 50% of the active ingredient is going up or down and can harm people. There is a Public Health Adivsory on Sudden Unexplained Death with Adderall products.
In short, you can't approve an Adderall IR approved at a 3:1 ratio, and then have an Adderall XR ratio change to 50:50.
Please remove all generic and brand Adderall Products from the market for safety and efficacy reasons.
I am neutral on my own petition as a potential conflict, however support above.