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Generic Drugs
A generic drug is identical, or
bioequivalent to a brand name drug in dosage form, safety, strength, route of
administration, quality, performance characteristics and intended use. Although
generic drugs are chemically identical to their branded counterparts, they are
typically sold at substantial discounts from the branded price. According to the
Congressional Budget Office, generic drugs save consumers an estimated $8 to $10
billion a year at retail pharmacies. Even more billions are saved when
hospitals use generics.
Drug companies must submit an abbreviated
new drug application (ANDA) for approval to market a generic product. The
Drug
Price Competition and Patent Term Restoration Act of 1984,
more commonly known as the Hatch-Waxman Act, made
ANDAs possible by creating a compromise in the drug industry. Generic drug
companies gained greater access to the market for prescription drugs, and
innovator companies gained restoration of patent life of their products lost
during FDA's approval process.
New drugs, like other new products, are
developed under patent protection. The patent protects the investment in the
drug's development by giving the company the sole right to sell the drug while
the patent is in effect. When patents or other periods of exclusivity expire,
manufacturers can apply to the FDA to sell generic versions. The ANDA process
does not require the drug sponsor to repeat costly animal and clinical research
on ingredients or dosage forms already approved for safety and effectiveness.
This applies to drugs first marketed after 1962.
Health professionals and
consumers can be assured that FDA approved generic drugs have met the same
rigid standards as the innovator drug. To gain FDA approval, a generic
drug must:
- contain the same active ingredients as the
innovator drug (inactive ingredients may vary)
- be identical in strength, dosage form, and route
of administration
- have the same use indications
- be bioequivalent
- meet the same batch requirements for identity,
strength, purity, and quality
- be manufactured under the same strict standards
of FDA's good manufacturing practice regulations required for innovator
products
For more information on the safety and
effectiveness of generic drugs, please see
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You can search for generic equivalents by
using the "Electronic Orange Book" at
http://www.fda.gov/cder/ob/default.htm and search by
proprietary "brand" name," then search again by using the active ingredient
name. If other manufacturers are listed besides the "brand name" manufacturer
when searching by the "active ingredient," they are the generic product
manufacturers.
Since there is a lag time after generic
products are approved and they appear in the "Orange Book," you should also
consult the most recent monthly approvals for "First Generics" at
http://www.fda.gov/cder/ogd/approvals/default.htm.
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- The Immediate Office of Generic Drugs has
moved to:
 (1/27/2006)
Metro Park North 4 (MPN 4) HFD-600
7519 Standish Place
Rockville, MD 20855
Main Number: 240-276-9310 FAX Number: 240-276-9327
- Presentations from the Generic
Pharmaceutical Association's 2006 Annual Meeting Business Exposition,
February 16-18, 2006. (3/7/2006)
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"Update from the Office of Generic Drugs"
 ,
Gary J. Buehler, Director, Office of Generic Drugs.
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"Update to the GPhA Technical Advisory Committee"
,
Gary J. Buehler, Director, Office of Generic Drugs.
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"Regulatory Assessment of Pharmaceutical Quality for Generic Drugs"
,
Lawrence Yu, Ph.D., Director for Science, Office of Generic Drugs.
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"Generic Labeling 2006"
,
Koung Lee, Reviewer, Labeling Review Branch, Division of Labeling
and Program Support, Office of Generic Drugs.
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Previous News items
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| Recent
Federal Register Notices |
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- Food and Drug Administration [Docket No.
2005N-0331] Able Laboratories, Inc.; Withdrawal of Approval of Ten
Abbreviated New Drug Applications [TXT]
[PDF]
(8/29/2005)
Summary: The Food and Drug Administration (FDA) is withdrawing approval of
ten abbreviated new drug applications (ANDAs) held by Able Laboratories,
Inc. (Able Labs), One Able Dr., Cranbury, NJ 08512. Able Labs has
initiated a class II recall of the products covered by these ANDAs. The
company has requested that the applications be withdrawn and has waived
its opportunity for a hearing.
- Food and Drug Administration [Docket No.
2005D-0312] Draft Guidance for Industry on Abbreviated New Drug
Applications: Impurities in Drug Products; Chemistry, Manufacturing, and
Controls Information; Availability [TXT]
[PDF](8/29/2005)
Summary: The Food and Drug Administration (FDA)
is announcing the availability of a draft guidance for industry entitled
``ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and
Controls Information.'' This draft guidance provides recommendations on
what chemistry, manufacturing, and controls information sponsors should
include regarding reporting, identification, qualification, and setting
acceptance criteria for impurities that are classified as degradation
products in drug products when submitting an abbreviated new drug
application (ANDA) or supplement to support changes in drug substance
synthesis or process, formulation of the drug product, the manufacturing
process, or components of the container/closure system.
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- ANDA Checklist for Completeness and
Acceptability [PDF]
[Word]
(
 1/17/2006)
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Inactive Ingredient Database The newly revised
Inactive Ingredients Database provides information on inactive ingredients
present in FDA-approved drug products. This information can be used by
industry as an aid in developing drug products.
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Bioequivalence Study Retention Samples.
(1/12/2001) Regulations state that applicants shall retain reserve
samples of the tested products administered to study subjects and release
these samples to FDA upon request. The Agency may then analyze these
retention samples to ensure that the BA/BE results upon which FDA bases
approval of New Drug Applications (NDA) and Abbreviated New Drug
Applications (ANDAs) are reliable.
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Abbreviated New Drug Application web page.
This
web page includes all the information needed to assist with preparing and
submitting ANDAs.
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FDA Letters to Industry This series of letters
informs generic drug product manufacturers of policy and procedure
developments with respect to the Drug Price Competition and Patent Term
Restoration Act of 1984.
- Generic Drug
Review Process. An interactive
chart that provides an overview of CDER's abbreviated new drug application
(ANDA) review process, and how CDER determines the safety and
bioequivalence of generic drug products prior to approval for marketing.
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Code of Federal Regulations |
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CFR 2.125 Use of chlorofluorocarbon propellants
in self-pressurized containers
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CFR 21 5.80 Approval of new drug applications
and their supplements
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CFR 21 10.30 Citizen Petition
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CFR 21 10.45 Court review of final
administrative action; exhaustion of administrative remedies
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CFR 21 50 Protection of Human Subjects
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CFR 21 56 Institutional Review Boards
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CFR 310.305 Records and reports concerning
adverse drug experiences on marketed prescription drugs for human use
without approved new drug applications
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CFR 314.70 Supplements and other changes to an
approved application
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CFR 320
Bioavailability and bioequivalence
requirements
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Federal Food, Drug, and Cosmetic Act |
- Draft Guidance
for Industry: Applications Covered by Section 505(b)(2).
Optional format:
PDF.
(Issued 10/1999, Posted 12/7/1999)
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Drug Price Competition and Patent Term Restoration Act of 1984
- Guidance for
Industry: 180-Day Generic Drug Exclusivity Under the Hatch-Waxman
Amendments to the Federal Food, Drug, and Cosmetic Act
(Issued 6/1998, Posted
6/22/1998)
- Court
Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman
Amendments to the Federal Food, Drug, and Cosmetic Act.
(Posted 3/27/2000)
- Qualifying for
Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and
Cosmetic Act. (Issued 9/1999, Posted
10/4/1999). The FDA Modernization Act of 1997 permits certain
applications to obtain an additional six months of marketing exclusivity
(pediatric exclusivity) if, in accordance with the requirements of the
statute, the sponsor submits requested information relating to the use of
the drug in the pediatric population.
- Useful pediatric
exclusivity links. This information is
provided to assist generic drug applicants in determining whether a drug
product might be or is subject to pediatric exclusivity.
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Food and Drug Administration Modernization Act of 1997 |
- FDA Modernization
Act of 1997: CDER-Related Documents. The Food
and Drug Administration Modernization Act (FDAMA), enacted Nov. 21, 1997,
amended the Federal Food, Drug, and Cosmetic Act relating to the
regulation of food, drugs, devices, and biological products. The Act
focuses on streamlining regulatory procedures, setting new priorities,
entering into novel collaborative arrangements, and carrying out
far-reaching managerial reforms within the Agency. Please see the
FDAMA Backgrounder
for a summary of the most important provisions of the Act.
Please see the FDA
Modernization Act home page for more
information.
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- Paragraph IV List
CFR 314.94(a)(12)(i)(A)(4)
...the applicant shall provide the patent number and certify, in its
opinion and to the best of its knowledge, ...that the patent is invalid,
unenforceable, or will not be infringed by the manufacture, use, or sale
of the drug product for which the abbreviated application is submitted.
The applicant shall entitle such a certification ``Paragraph IV
Certification''.
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Under the
Drug Price Competition and Patent Term Restoration Act,
or the Hatch-Waxman Act, a company can seek approval from FDA to market a
generic drug before the expiration of a patent relating to the brand name drug
upon which the generic is based. The first company to submit an Abbreviated New
Drug Application (ANDA) with the FDA has the exclusive right to market the
generic drug for 180 days.
To begin the FDA approval process, the
generic applicant must: 1) certify in its ANDA that the patent in question is
invalid or is not infringed by the generic product (known as "paragraph IV
certification"); and 2) notify the patent holder of the submission of the ANDA.
If the patent holder files an infringement suit against the generic applicant
within 45 days of the ANDA notification, FDA approval to market the generic drug
is automatically postponed for 30 months, unless, before that time, the patent
expires or is judged to be invalid or not infringed. This 30-month postponement
allows the patent holder time to assert its patent rights in court before a
generic competitor is permitted to enter.
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These petitions are submitted to FDA by
drug companies seeking permission to file an abbreviated new drug application
for a change from a listed drug in dosage form, strength, route of
administration, or active ingredient in a combination product. If FDA
determines that the drug is suitable for a generic product, the petition is
approved, if it is not suitable, the petition is denied.
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