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U.S. Department of Health and Human Services

Drugs

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Previous News and Announcements (Generic Drugs)

 

News and Announcements  

  • On November 29, 2005, CDER rescinded the November 18, 2005 approval of Kali Laboratories' ANDA 76-506 for Ondansetron Orally Disintegrating Tablets, 4 mg and 8 mg.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?" (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.
    

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] (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)
 

Contact FDA

240-402-7920
301-595-1147 Fax
Office of Generic Drugs

Immediate Office

10903 New Hampshire Avenue

Silver Spring, MD 20993