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Orphan Drug Report 2012
thinkBiotech LLC, Jan 2012, Pages: 448
Profiles pharmaceutical drugs with FDA Orphan Drug Exclusivity
This report profiles the pharmaceutical drugs with Orphan Drug Exclusivity granted by the FDA
The following terms are used in this report:
Applicant
The firm holding legal responsibility for the new drug application.
Trade Name
The trade name of the product as shown on the labeling.
Generic Name / Ingredient
The active ingredient(s) for the product. Multiple ingredients are in alphabetical order separated by a semicolon.
New Drug Application (NDA) Number
The FDA-assigned number to the application.
Product Number
The FDA-assigned number to identify the application products. Each strength is a separate product.
Approval Date
The date the product was approved as stated in the FDA approval letter to the applicant.
Reference Listed Drug (RLD)
The pioneer or innovator version of the drug. The RLD identifies the product Abbreviated New Drug
Applications (ANDA) use as a reference.
Therapeutic Equivalence (TE) Code
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
The two basic categories into which multisource drugs have been placed are indicated by the first letter as follows:
A
Drug products that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which:
1. there are no known or suspected bioequivalence problems. These are designated AA, AN, AO, AP, or AT, depending on the dosage form; or
2. actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence. These are designated AB.
B
Drug products that FDA at this time, considers NOT to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence. Often the problem is with specific dosage forms rather than with the active ingredients. These are designated BC, BD, BE, BN, BP, BR, BS, BT, BX, or B*.
Product samples
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