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Office of Generic
Drugs:
Previous
News, Announcements and Federal Register Notices
News and Announcements
- Beginning October 1, 2007, all newly received Abbreviated New Drug Applications (ANDAs) will be numbered sequentially in the 90-000 series including those that previously would have been numbered in the 40-000, 60-000, 70-000 and 80-000 series. This will further streamline the receiving process for ANDAs.
- Guidance for Industry: Individual Product Bioequivalence Recommendations
- FDA addresses issues on Amlodipine Abbreviated New Drug Application Approvals
- Orange Book FR Safety or Effectiveness Determinations List (7/22/2008) The following is a list of approved drug products that have had Federal Register Citizen Petition Notices stating that the FDA has determined that the approved drug product was not discontinued for safety or effectiveness reasons. Under § 314.161(a)(1) [21 CFR 314.161(a)(1)], the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. The Federal Register Notice will allow FDA to approve applications (ANDAs) for the product if all other legal and regulatory requirements are met. The list is from 1995.
- FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic Studies Used in the Approval of a Number of Drug Products. Information (1/10/2007)
- Manual of Policies and Procedures (MaPP): 5240.3R Review Order of Original ANDAs, Amendments, and Supplements
- FDA's Clarification of Aripiprazole Tablets' Bioequivalence Requirements
- FDA's Clarification of the Patent Status for Simvastatin
- FDA's Clarification of Pravastatin's Exclusivity
- Presentations from the Generic Pharmaceutical Association's 2006 Annual Meeting Business Exposition, February 16-18, 2006. (3/7/2006)
- "Update from the Office of Generic Drugs" , Gary J. Buehler, Director, Office of Generic Drugs.
- "Update to the GPhA Technical Advisory Committee" , Gary J. Buehler, Director, Office of Generic Drugs.
- "Regulatory Assessment of Pharmaceutical Quality for Generic Drugs" , Lawrence Yu, Ph.D., Director for Science, Office of Generic Drugs.
- "Generic Labeling 2006" , Koung Lee, Reviewer, Labeling Review Branch, Division of Labeling and Program Support, Office of Generic Drugs.
- 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
- On
November 29, 2005, CDER rescinded the November 18, 2005 approval
of Kali Laboratories' ANDA 76-506 for Ondansetron Orally
Disintegrating Tablets, 4 mg and 8 mg. The reference listed drug
for this ANDA is Zofran (GlaxoSmithKline), which is used to
treat nausea and vomiting. CDER took this action because the
U.S. District Court for the District of New Jersey issued a
decision finding that this ANDA infringes a patent of
GlaxoSmithKline that has not yet expired. Pediatric exclusivity
attaches to this patent, and is not due to expire until December
24, 2006. Kali has informed CDER that Kali has appealed this
court decision. (11/29/2005)
- Presentations from the Generic Pharmaceutical Association's
Fall Technical Conference, October 24-26, 2005, Washington, DC. (11/8/2005)
- "OGD Perspectives," Gary J. Buehler, Director, Office of
Generic Drugs. [PPT]
- "Question-Based Review: An Enhanced Pharmaceutical Quality
Assessment System," Lawrence Yu, Ph.D., [PPT]
- The Office of Generic Drugs (OGD) is developing a question
based review (QbR) for the Chemistry, Manufacturing, and
Controls (CMC) evaluation of an Abbreviated New Drug Application
(ANDA) that is focused on critical pharmaceutical quality
attributes. QbR Information (8/31/2005)
- On June 15, 2005, the Office of Generic Drugs (OGD)
granted a tentative approval for the Abbreviated New Drug
Application (ANDA) 77-464 for Lamivudine Tablets, 150 mg and 300 mg
held by Aurobindo Pharma Ltd. Hyderabad, India. Lamivudine Tablets
are indicated for use in combination with other antiretroviral
agents for the treatment of HIV-l infection.
This is the second application for Lamivudine Tablets for which FDA
granted tentative approval granted under the President's Emergency
Plan for Aids Relief (PEPFAR) expedited review program. On May 27,
2005, OGD granted tentative approval to ANDA 77-357 held by Ranbaxy
Laboratories Limited, for Lamivudine Tablets, 150 mg. On December 3,
2004, OGD granted full approval to the first PEPFAR ANDA, 77-167,
held by Barr Laboratories, Inc. for Didanosine Delayed-release
Capsules. (6/15/2005)
FDA News: Tentatively Approves a Generic AIDS Drug under the
President’s Emergency Plan for AIDS Relief (6/15/2005)
- Office Director, Gary Buehler, to present at the FDA Science
Forum "Advancing Public Health Through Innovative Science", Tuesday,
April 26, 2005. Gary Buehler will be presenting with Jack Billi,
M.D., Associate Vice President, University of Michigan, "Generic
Drugs - Are They Really as Good?" The
complete program and registration form is found at
http://www.fda.gov/scienceforum. (4/15/2005)
-
Office of Generic Drugs (OGD) announces its
continuing participation in the Plant Tours Program for fiscal year
2005. The goal of this program is to provide OGD review and support
staff, from all review disciplines, with enhanced awareness of
critical functions of drug product development, manufacturing, and
regulatory submissions. Moreover, we hope this program will foster
improved communications between OGD staff and industry on issues of
mutual interest. Ultimately, we hope participation in this program
can lead to better ANDA submissions and increased efficiency and
quality of reviews. (2/7/2005)
Firms interested in hosting OGD for this Plant Tours Program should
contact LCDR Peter Chen at 301-827-5773. Proposed agenda must be
submitted before March 31, 2005. Plant tours usually last 1-2 days
with 10-15 participants from OGD and are limited to territories
within the United States. All travel expenses for OGD staff are the
responsibility of OGD. Selection of tours will be based on the
availability of funds for the fiscal year. Funds are usually
available from May through August, and tours will only be scheduled
for this timeframe.
-
Office of Generic Drugs -
Statement on Expedited Review of Generic Drug Products for the
Prophylaxis and Treatment of Illness Caused by Various Strains of
the Influenza Virus (10/18/2004)
In the absence of influenza vaccine, many health practitioners and
patients will turn to the use of drug products such as amantadine
hydrochloride and rimantadine hydrochloride which are approved for
the prophylaxis and treatment of illness caused by various strains
of the influenza virus. Fortunately, both of these drugs are
available from multiple generic sources. (Posted 10/18/2004)
In an effort to assure that adequate quantities of these products
will be available for use by the American public, the Office of
Generic Drugs (OGD) is granting "expedited review" status to all
pending supplements in the review queues for all dosage forms of
these two drug products. This policy will be in effect for 90 days
and will be reassessed as necessary.
- Presentations from the Generic Pharmaceutical Association's
Annual Meeting, February 29- March 2, 2004. (Posted 3/5/2004)
- Update from the Office of Generic Drugs, Gary J. Buehler,
Director, Office of Generic Drugs. [PPT
slides] or [HTML]
- Office of Generic Drugs: Some Scientific Initiatives, Lawrence
Yu, Ph.D., Director for Science, Office of Generic Drugs. [PPT
Slides] or [HTML]
- The Inactive
Ingredient Database has a new feature. On the main search page,
click on "About this Database." Question 11 has a downloadable
zipped text file, IIGZIP.EXE, that is used for the query. The file
can be downloaded, imported into Access or Excel, for sorting,
analysis, reports, etc. The link is:
http://www.fda.gov/cder/iig/iigfaqWEB.htm"
(2/9/2004)
- Effective 1 Oct, 2003, the Office of Regulatory Affairs (ORA)
issued the required notification on Dockets (92S-0251) that ORA is
able to access electronic CMC submissions through CDER's Electronic
Document Room. This includes both NDAs and ANDAs. Sponsors
submitting electronic submissions to CDER do not need to submit an
e-submission or paper submission to the ORA District office. ORA
requests that the sponsor submit a letter to their home district
certifying that the electronic CMC sections has been submitted to
CDER.
Dockets announcement
- Suggestions for Improving "Controlled Correspondence" to the Office of Generic Drugs.
(Posted 8/27/2003)
- Shared Exclusivity for Paroxetine Hydrochloride Tablets [HTML]
or [Word]
(Posted 8/4/2003)
- On June 26, 2003, a Generic Pharmaceutical Association/Office of
Generic Drugs joint meeting was held as a collaborative effort
directed at improving the Generic Drug Approval Process. Meeting
agenda and presentations.
- On June 12, 2003, FDA announced new regulations and review
procedures to streamline the process for making safe, effective
generic drugs available to consumers. FDA
Generic Drugs Final Rule and Initiative Information Page
(Posted 6/23/2003)
- Proceedings from the Office of Generic Drugs "Clonidine
Transdermal Systems Meeting", April 29, 2003. (Posted 6/13/2003) [WORD] or [PDF]
- Exclusivity Determination for
Gabapentin
(Issued 1/28/2003, Posted 1/29/2003)
- Presentation: The FDA Process for Approving Generic
Drugs,
Gary J Buehler, R.Ph., Director, Office of Generic Drugs, October
29, 2002. (Posted 11/7/2002)
- October 15-16, 2002, Generic Pharmaceutical Association 2002 Fall
Technical Workshop, Hyatt Regency, Bethesda, MD: The Generic Pharmaceutical
Industry: Regulatory and Scientific Challenges. Agenda
and registration.
(10/4/2002)
- Proceedings from the Symposium on the Hatch-Waxman Act, January
30, 2002, Rockville, MD. (Posted 6/6/2002)
- April 8-12, 2002, Generic Pharmaceutical Association Annual
Meeting and Educational Conference - Presentations.
(Posted 4/15/2002)
- Shared Exclusivity for
Omeprazole. (Posted 12/14/2001)
Federal Register
Notices
- Food and Drug Administration [Docket No. 2003P-0501] Determination
That Pyridostigmine Bromide Tablets, 30 Milligrams, Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness. [TXT]
[PDF]
(6/23/2005)
Summary: The Food and Drug Administration (FDA) has determined
that Pyridostigmine Bromide tablets, 30 milligrams (mg), for the
treatment of myasthenia gravis, were not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow
FDA to approve abbreviated new drug applications (ANDAs) for
Pyridostigmine Bromide tablets, 30 mg, for the treatment of
myasthenia gravis.
- Food and Drug Administration [Docket No. 2003D-0549] Guidance
for Industry on Clozapine Tablets: In Vivo Bioequivalence and In
Vitro Dissolution Testing; Availability [TXT]
[PDF]
(6/20/2005)
Summary: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled "Clozapine Tablets:
In Vivo Bioequivalence and In Vitro Dissolution Testing.'' The
guidance was originally published in November 1996. However, because
of potentially significant adverse effects seen in healthy subjects
who had not previously used clozapine, FDA proposed a revision to
the guidance in a draft published in December 2003. FDA did not
receive comments on the draft guidance during the comment period.
This final version of the 2003 draft guidance includes a change in
the recommended patient population as well as other minor changes
that are based on current information available to FDA.
-
Food and Drug Administration; Determination That Zithromax (Azithromycin)
250-Milligram Oral Capsules Were Not Withdrawn From Sale for Reasons
of Safety or Effectiveness: Notice.
[TXT]
[PDF]
(5/20/2005)
Summary: The Food and Drug Administration
(FDA) has determined that Zithromax (azithromycin) 250-milligram
(mg) oral capsules were not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to
approve abbreviated new drug applications (ANDAs) for azithromycin
250-mg oral capsules.
- Food and Drug Administration; [Docket No. 2002D-0389]
(formerly 02D-0389) Guidance for Industry on Nonclinical Studies for
the Safety Evaluation of Pharmaceutical Excipients; Notice. [TXT]
[PDF]
(5/20/2005)
Summary: The Food and Drug
Administration (FDA) is announcing the availability of a guidance
for industry entitled ``Nonclinical Studies for the Safety
Evaluation of Pharmaceutical Excipients.'' This document is intended
to provide guidance on the types of toxicity information that FDA
recommends be provided to the agency to support the use of new
excipients in drug products. Previously, such information was not
available to drug sponsors in a written document. This information
should allow drug sponsors to determine if a potential new excipient
is safe to use in drug products.
- Food and Drug Administration, CollaGenex
Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug
Application; Determination That Doxycycline Hyclate 20-Milligram
Capsules Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness: Notice. [TXT]
[PDF]
(5/18/2005)
Summary: FDA is withdrawing approval of one
new drug application (NDA). CollaGenex Pharmaceuticals, Inc.,
notified the agency in writing that PERIOSTAT (doxycycline hyclate)
20- milligram (mg) capsules were no longer marketed and requested
that approval of NDA 50-774 be withdrawn. FDA has determined that
PERIOSTAT (doxycycline hyclate) 20-mg capsules were not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs)
for doxycycline hyclate 20-mg capsules.
- Food and Drug Administration [Docket No. 2005N-0058] Hospira,
Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and
60 Abbreviated New Drug Applications; Notice; correction. [TXT]
[PDF]
(4/26/2005)
Summary: FDA is correcting a notice that
appeared in the Federal Register of March 4, 2005 (70 FR 10651). The
document announced the withdrawal of approval of 76 new drug
applications (NDAs) and 60 abbreviated new drug applications (ANDAs).
The document inadvertently withdrew approval of ANDA 76-214 for
Sotalol Hydrochloride Tablets, 80 milligrams (mg), 120 mg, and 160
mg, held by TorPharm, c/o Apotex Corp., 616 Heathrow Dr.,
Lincolnshire, IL 60069. FDA confirms that approval of ANDA 76-214 is
still in effect.
- Guidance for Industry on Providing Regulatory Submissions in
Electronic Format--Content of Labeling;
Notice of Availability [TXT]
[PDF].
The Guidance [PDF]
(4/21/2005)
Summary: FDA is announcing the
availability of a guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format--Content of Labeling.''
This guidance is one in a series of guidance documents on providing
regulatory submissions to FDA in electronic format. FDA's
regulations require that the content of labeling for marketing
applications be submitted in electronic format in a form that FDA
can process, review, and archive. The guidance provides information
on submitting the content of labeling in electronic format for
review with new drug applications (NDAs), abbreviated new drug
applications (ANDAs), and biological license applications (BLAs) for
biological products that meet the definition of drug in the Federal
Food, Drug, and Cosmetic Act.
- (3/25/2005) Hospira, Inc. et
al.; Withdrawal of Approval of 76 New Drug Applications and 60
Abbreviated New Drug Applications: Notice. [TXT]
[PDF]
Effective on April 4, 2005.
Summary: The Food and Drug
Administration (FDA) is withdrawing approval of 76 new drug
applications (NDAs) and 60 abbreviated new drug applications (ANDAs)
from multiple applicants. The holders of the applications notified
the agency in writing that the drug products were no longer marketed
and requested that the approval of the applications be withdrawn.
- Draft Guidance for Industry on ANDAs: Pharmaceutical Solid
Polymorphism; Chemistry, Manufacturing, and Controls Informational;
Availability. [TXT]
[PDF] (12/20/2004)
SUMMARY: This draft guidance is
intended to assist applicants with the submission of abbreviated new
drug applications (ANDAs) when a drug substance exists in
polymorphic forms.
- Guidance for Industry on
Changes to an Approved New Drug Application or Abbreviated New Drug
Application; Specifications-Use of Enforcement Discretion for
Compendial Changes. [TXT]
[PDF]
Summary: The Food and Drug
Administration (FDA) is announcing the availability of a guidance
for industry entitled ``Changes to an Approved NDA or ANDA;
Specifications--Use of Enforcement Discretion for Compendial
Changes.'' This guidance informs new drug application (NDA) and
abbreviated new drug application (ANDA) holders of FDA's plan to use
enforcement discretion with regard to the regulation on changes to
an approved application. This regulation describes the filing
requirement that a relaxation of acceptance criteria or deletion of
a test to comply with an official compendium must be reported in a
changes-being-effected-in-30-days supplement (CBE-30). FDA does not
intend to take enforcement action if manufacturers continue to
submit such changes in their annual reports. The use of enforcement
discretion will give the agency time to clarify that some of these
types of postapproval changes can be submitted in an annual report,
rather than in a CBE-30. The agency intends to clarify this issue in
an upcoming revision to a guidance for industry.
- Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and
Approval of Abbreviated New Drug Applications and 505(b)(2)
Applications Under Hatch-Waxman, as Amended by the Medicare
Prescription Drug, Improvement, and Modernization Act of
2003--Questions and Answers; Availability. [TXT]
[PDF]
Comments on draft guidance due
February 2, 2005.
- Draft Guidance for Industry
on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2)
Applications Under Hatch-Waxman, as Amended by the Medicare
Prescription Drug, Improvement, and Modernization Act of
2003--Questions and Answers; Availability; Correction. [TXT]
[PDF]
Comments by November 19, 2005
Applications through December 31, 2004 (Posted 11/22/2004)
Summary: FDA is correcting a notice that appeared in the
Federal Register of November 4, 2004. This document announced the
availability of a draft guidance for industry entitled ``Listed
Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2)
Applications Under Hatch-Waxman, as Amended by the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003--
Questions and Answers.'' The document was published with an
incorrect docket number. This document corrects that error.
- Determination That Serzone (Nefazodone
Hydrochloride) Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness, Notice [TXT]
[PDF]
- Summary: The Food and Drug Administration (FDA) has determined
that Serzone (nefazodone hydrochloride (HCl)) was not withdrawn from
sale for reasons of safety or effectiveness. This determination
means that FDA will not begin procedures to suspend approval of
abbreviated new drug applications (ANDAs) for nefazodone HCl, and
FDA may continue to approve ANDAs for nefazodone HCl. (Posted 10/26/2004)
- Application of
30-Month Stays on Approval of Abbreviated New Drug Applications and
Certain New Drug Applications Containing a Certification That a
Patent Claiming the Drug Is Invalid or Will Not Be Infringed;
Technical Amendment. [TXT]
[PDF]
Effective date: March 10, 2004 (Posted
3/10/2004)
-
Over-the-Counter Drug Products; Safety and Effficacy Review;
Additional Dandruff Control Ingredient. [TXT]
[PDF]
Comments due May 18, 2004. (Posted
2/20/2004).
- Determination That Chlorthalidone Tablets and Seven Other Drug
Products Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness. [TXT]
[PDF]
(Posted 2/20/2004)
- Agency Information Collection Activities; Comment Request;
Guidance for Industry--Changes to an Approved New Drug Application
or Abbreviated New Drug Application. (Posted 12/19/2003) [TXT]
[PDF]
Comments Due February 17, 2004
- Draft Guidance for Industry on Powder Blends and Finished Dosage
Units--Stratified In-Process Dosage Unit Sampling and Assessment;
Availability [TXT]
[PDF]
Comments by March 8, 2004
- Requirements for Submission of In Vivo Bioequivalence Data;
Proposed Rule. [TXT]
[PDF].
Comments January 27, 2004
(Posted 10/29/2003)
- Review and Revision of Guidances for Industry on
the Development of Generic Drug Products; Development and Use of
Food and Drug Administration Guidance Documents; Update and
Withdrawal of Guidances. [TXT]
[PDF]
(Posted 10/27/2003)
- Draft Guidance for Industry on Providing Regulatory Submissions
in Electronic Format--Annual Reports for New Drug Applications and
Abbreviated New Drug Applications; Availability [TXT]
or [PDF] (Posted
8/2003)
- Applications for FDA Approval to Market a New Drug: Patent
Submission and Listing Requirements and Application of 30-Month
Stays on Approval of Abbreviated New Drug Applications Certifying
That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed.
[TXT]
[PDF]
Effective August 18, 2003.
- International Conference on Harmonisation; Guidance on
Electronic Common Technical Document Specification; Availability.
[TXT]
[PDF]
Comments April 2, 2004. (Posted
4/7/2003)
- Draft Guidance for Industry: Bioavailability and Bioequivalence
Studies for Nasal Aerosols and Nasal Sprays for Local Action;
Availability [TXT]
[PDF]
-
Guidance for Industry on Food-Effect Bioavailability and Fed
Bioequivalence Studies; Availability. [TXT]
[PDF]
(Issued and Posted 1/31/2003)
- Bioavailability and Bioequivalence Requirements;
Abbreviated Applications; Final Rule. [TXT]
[PDF]
(Issued and posted 12/19/2002)
- Labeling of Diphenhydramine-Containing Drug Products
for Over-the-Counter Human Use. [TXT]
[PDF]
(Issued 12/6/2002, Posted 12/9/2002)
- Determination That Sodium Tetradecyl Sulfate
Injection Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness. [TXT]
[PDF]
(Issued and Posted 11/7/2002)
- 180-Day Generic Drug Exclusivity for Abbreviated New
Drug Applications; Proposed rule; withdrawal. [TXT]
[PDF]
(Issued and Posted 11/1/2002)
- Guidance for Industry on Labeling Over-the-Counter
Human Drug Products--Updating Labeling in Reference Listed Drugs and
Abbreviated New Drug Applications; Availability. [TXT]
[PDF].
(Issued 10/18/2002, Posted 10/22/2002).
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Date Updated, February 25, 2009 |
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