Proton Pump Inhibitors - CME Conferences
Proton Pump Inhibitors - CME Conferences
Proton Pump Inhibitors - CME Conferences
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
6 th Annual Primary Care Spring Conference Thursday, April 12, 2012<br />
How Did the<br />
“Orange Book” Get it’s Nickname?<br />
• When the first print edition of Approved Drug Products with<br />
Therapeutic Equivalence Evaluations was being prepared October<br />
1980, staff members in the Office of Generic Drugs had to choose a<br />
color for the cover. The project manager suggested, "It's almost<br />
Halloween. How about orange?"<br />
“Orange Book”<br />
FDA<br />
• All FDA approved drug products listed<br />
(NDA’s, OTC’s & ANDA’s)<br />
• Therapeutic equivalence codes<br />
–“A” = Substitutable<br />
–“B” = Inequivalent, NOT substitutable<br />
• Expiration dates: patent and exclusivity<br />
• Reference Listed Drugs/brand drugs identified by<br />
FDA for generic companies to compare their<br />
proposed products with<br />
Center for Drug Evaluation and Research<br />
Wayne Weart, Pharm D<br />
Cost Effective Rx