NEW DATABASE EXPECTED TO SPEED UP ANDA APPROVALS
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.
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