FDAnews Drug Daily Bulletin


Nov. 15, 2005

The FDA's Office of Generic Drugs (OGD) has launched its Dissolution Methods Database aimed at improving the quality and turnaround time of abbreviated new drug applications (ANDAs).

With the database, which went online recently, the OGD aims to provide recommendations for generic drug companies to establish dissolution. Dissolution is the breaking down of a drug product in the body.

Generic Pharmaceutical Association (GPhA) spokeswoman Andrea Hoeflich called the database a "welcome development for the generic industry." The tool should help shorten approval times for ANDAs and reduce uncertainty over ANDA requirements, Hoeflich told FDAnews. The OGD has said that many of the questions it receives from manufacturers about generic drugs pertain to the dissolution issue.

As it is, generic drug approvals are not keeping pace with the rising number of applications. In fiscal year 2005, OGD received 766 applications, compared to 563 in fiscal year 2004, but the number of approvals only rose from 413 to 467, OGD Director Gary Buehler said at the recent GPhA Technical Conference. At the end of fiscal 2005, there were 780 original ANDAs pending at the FDA, compared to 615 at the end of fiscal 2004, he said.

The new database, which provides information on dissolution methods presently recommended by the FDA's Division of Bioequivalence, currently contains information for 214 drugs and will be updated quarterly. It is searchable by a product's generic name and contains: the established name of the product; dosage form; recommended USP (U.S. Pharmacopeia) apparatus; speed; medium and volume; recommended sampling times; and the date that the recommendation was provided or updated.

The database is part of a larger effort to help firms improve the quality of their generic drug applications, an effort that has already resulted in more frequent updates to the FDA's Orange Book. The OGD is also planning to post a guidance that will link to a list of drugs and their corresponding bioequivalency recommendations, Buehler said at the GPhA conference. The database will provide bioequivalence recommendations for older drugs as well as drugs not yet off patent.

The Dissolution Methods Database can be found at http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm.