Office of Generic Drugs: 
Previous News, Announcements and Federal Register Notices

News and Announcements

• 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• On November 29, 2005, CDER rescinded the November 18, 2005 approval of Kali Laboratories' ANDA 76-506 for Ondansetron Orally Disintegrating Tablets, 4 mg and 8 mg.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) 
  • Generic Pharmaceutical Association (GPhA) Materials for 1/30/2002 Meeting with FDA.
  • Pharmaceutical Research and Manufacturers of America: White Paper on Implementation of the Hatch-Waxman Act by the U.S. Food and Drug Administration
  • Generic Pharmaceutical Association Submission to FDA: Reply
  • Pharmaceutical Research and Manufacturers of America:  Response to Written and Oral Submissions by the Generic Pharmaceutical Association on Implementation of the Hatch-Waxman Act by the U.S. Food and Drug Administration.
    
    
• April 8-12, 2002, Generic Pharmaceutical Association Annual Meeting and Educational Conference -  Presentations.  (Posted 4/15/2002)
  • Update from the Office of Generic Drugs
  • Current Bioequivalence Issues
     
• Shared Exclusivity for Omeprazole.  (Posted 12/14/2001)   

Federal Register Notices

• Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Informational; Availability.   [TXT] [PDF]  (12/20/2004)
  •  The Draft Guidance (PDF) or (Word)

  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]  
  • The Guidance  (Posted 11/22/2004)

  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.

• 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

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

FDA/Center for Drug Evaluation and Research