Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA.
Summary of "Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA."
The Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability. The objective of this study was to use the World Health Organization Model List of Essential Medicines to determine the distribution of BCS Class 1, 2, 3, and 4 drugs in Abbreviated New drug Applications (ANDA) submissions. To categorize solubility and intestinal permeability properties of generic drugs under development, we used a list of 61 drugs which were classified as BCS 1, 2, 3, and 4 drugs with certainty in the World Health Organization Model List of Essential Medicines. Applying this list to evaluation of 263 ANDA approvals of BCS drugs during the period of 2000 to 2011 indicated 110 approvals (41.8%) for Class 1 drugs (based on both biowaiver and in vivo bioequivalence studies), 55 (20.9%) approvals for Class 2 drugs, 98 (37.3%) approvals for Class 3 drugs, and no (0%) approvals for Class 4 drugs. The present data indicated a trend of more ANDA approvals of BCS Class 1 drugs than Class 3 or Class 2 drugs. Antiallergic drugs in Class 1, drugs for pain relief in Class 2 and antidiabetic drugs in Class 3 have received the largest number of approvals during this period.
Affiliation
Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 7520 Standish Place, Rockville, Maryland, 20855, USA, Anil.Nair@fda.hhs.gov.
Journal Details
This article was published in the following journal.
Name: The AAPS journal
ISSN: 1550-7416
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/22718306
- DOI: http://dx.doi.org/10.1208/s12248-012-9384-z
Medical and Biotech [MESH] Definitions
Off-label Use
The practice of prescribing or using a drug outside the scope of the drug's official approved label as designated by a regulatory agency concerning the treatment of a particular disease or condition.
Vital Statistics
Used for general articles concerning statistics of births, deaths, marriages, etc.
Drugs, Generic
Drugs whose drug name is not protected by a trademark. They may be manufactured by several companies.
National Center For Health Statistics (u.s.)
A center in the PUBLIC HEALTH SERVICE which is primarily concerned with the collection, analysis, and dissemination of health statistics on vital events and health activities to reflect the health status of people, health needs, and health resources.
Drug Packaging
Containers, packaging, and packaging materials for drugs and biological products. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance. Similar laws govern use elsewhere. (From Code of Federal Regulations, 21 CFR 1 Section 210, 1993) DRUG LABELING is also available.
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