DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/acde9d/orphan_drug_report) has announced the addition of the "Orphan Drug Report 2011" report to their offering.
The Orphan Drug Report 2011 profiles pharmaceutical drugs with FDA 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*.
Key Topics Covered:
- Orphan Drug List
- Orphan Drug Details
- MVI-12 (WITHOUT VITAMIN K)
- NORMOCARB HF 25
- Data Sources
For more information visit http://www.researchandmarkets.com/research/acde9d/orphan_drug_report
Research and Markets
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