Orange Book
Orange Book
Orange Book
Orange Book
FDAs list of all drugs approved in USA as safe & effective Authoritative Source of Information on the Therapeutic Equivalence of Drug Products
1950s
Many states enacted laws banning substitution of drugs Economic pressure led to repeal of these anti substitution laws
1970s
In order to regulate substitution, FDA announced its intention to create list of approved drugs & Therapeutic Equivalence determination
1st Edition
October 1980
5 Main Sections:
Introduction
Drug Product List
Appendices
Patent Exclusivity Info Addendum
Drug products which contain the same Pharmaceutical active ingredients in the same strength Equivalents and dosage form delivered by the same route of administration
Those products which have shown comparable bioavailability when studied under similar conditions (e.g. the rate and extent of absorption of a test drug does not significantly differ from that of the reference drug)
Therapeutic Equivalents
Pharmaceutical Equivalents that are Bioequivalent. Only drugs which are Therapeutic Equivalents may be legally substituted for FDA approved drugs in Orange Book.
T.E. CODES
A DRUGS
AA (no known or suspected BE problems)
AB (actual or potential BE problems have been resolved
B DRUGS
The listed drug identified by FDA as the drug product upon which applicant relies in seeking approval of its ANDA Bioequivalence to the innovator drug product must be proven. Once proven, the generic drug is listed in the ORANGE BOOK
Designating a Single Reference Listed Drug as Standard FDA hopes to avoid possible Generic variations
Multi Source
Pharmaceutical Equivalents available from more than one manufacturer. Therapeutic Equivalence code is included (Section 505)
Only one approved product available Single Source for that active ingredient, dosage form, route of administration & strength. No Therapeutic Code included.
FDA Considers therapeutically equivalent & therefore substitutable Multisource drug products listed under the same heading and having same strength generally will be coded AB In certain instances, a number is added to the end of AB code to make it 3 character code (AB1, AB2, etc) Assigned only in situations when more than one reference listed drug of the same strength has been designated under same heading
BC BD BE BS BT
BX
BN BP
BR
Amino Acid & These products differ in amount and Protein kinds of amino acids they contain. Hydrolysate Considered TE where nitrogen balance is sole objective injections Waived Exclusivity
For an NDA qualifies for exclusivity, the FDA will delay approval of application ANDA until the expiration of exclusivity
Before making changes FDA announces Introduction & invites Comments Comments along with BE data sent to Director, Division of BE Comment period will generally be 60 days
Identifies drug that qualify under the Drug Price Competition and Patent Restoration Act for period of exclusivity
It Prevents submission or effective approval of ANDAs