Intellipharmaceutics International Inc. (IPCI)

[dtstx]

For anyone who may be interested. While I was researching the launch of Focalin 40mg by TEVA, the lack of the launch of lesser dosages by TEVA and the shortages of the drug going back 5+ yrs., it became apparent something wasn't right. It will be interesting if we launch the 40mg within a couple of weeks from the 28th of Nov. just as TEVA did when we lost our exclusivity at the end of May. The question will be, will Par get additional methylphenidate to make the tablets. Hopefully they won't have a problem and will launch as they have done before.

It would appear the drug is a Schedule 2 controlled substance listed in the Controlled Substance Act (CSA) listings. This falls under the stewardship and control of the Drug Enforcement Administration (DEA). Schedule 1 drugs aren't legal. Schedule 2 drugs are considered to have a "high potential for abuse" so they're monitored and quotas approved as they deem appropriate. The problem is the DEA is behind the curve, not in front, and seem to feel we have adequate supply to meet the need. Their position seems to be the drug companys' control the supply to the most lucrative markets at the expense of the cheaper generics. Thus the general public hasn't been getting the benefit which is acknowledged in my last post in 1 of the links. Teva had launched the lesser strengths yrs ago but pulled them. The DEA also feels the drug is oversubscribed and abused and therefore supply is adequate. As in 1 of the links I've provided, the FDA has been countering their claims but the DEA has the power it seems. The links are 2-3yrs old but it does show us how long this has been a problem. Granted this may not affect us when we have approval for the 40 mg but unless this political quagmire comes to some sort of victory for the consumer, Teva won't/can't relaunch their lower Focalin strengths keeping us out of those markets it would seem.

I hope we have greater flexability and less regulation to be concerned about when our opiods go to market as they're listed as well.

May be nothing to be concerned over but I personally like to be informed of what's going on especially when things don't add up and our free market system is being tampered with especially at the expense of the general public. The need is rising each yr. Hopefully they'll get ahead of the curve instead of behind. They did raise quotas 2 yrs ago but apparently still not enough.

Note: There're links inside the links for additional info.




http://www.nytimes.com/2012/01/01/health/policy/fda-is-finding-attention-drugs-in-short-supply.html?pagewanted=1&_r=3&;


http://psychcentral.com/blog/archives/2012/01/02/dea-doesnt-care-about-adhd-medication-shortage/


http://www.raps.org/focus-online/news/news-article-view/article/1880/dea-to-increase-supply-of-adhd-opioid-ingredients-in-light-of-shortages.aspx