Generic Drugs: Information for Industry
Activities Report of the Generic Drug Program (November 2013)
- FDA Announces the selection of Kathleen Uhl, M.D. as the Acting Director of the Office of Generic Drugs (OGD) effective March 25, 2013.
- The Office of Generic Drugs recently released a draft update to the question-based review framework (PDF - 29KB). The generics industry is encouraged to go through the draft and provide any feedback or suggestions.
- Recent meeting between FDA and International Pharmaceutical Excipients Council (IPEC).
- FDA Presentation: "Defining Excipients in the Substance Registration System" (PDF - 221KB) - Larry Callahan, Frank Switzer, Yulia Boradina, Tyler Peryea
- IPEC Presentation: "IPEC-OGD Meeting Inactive Ingredient Database Issues with ANDAs" (PDF - 381KB)
- December 2011 Meeting Minutes (PDF - 19KB)
- IPEC Americas-OGD Meeting, Inactive Ingredient Database (IID) (May 18, 2012) (PDF 58KB)
- IPEC HPMC IID Table (June 2012) (PDF - 149KB)
- IPEC PEO IID Table (June 2012) (PDF - 90KB)
- HPMC IID spreadsheet (May 17, 2012) (PDF - 132KB)
- Polyethylene Oxide IID spreadsheet (May 17, 2012) (PDF - 82KB)
- Backgrounder Document: "Inactive Ingredient Database Issues with ANDAs" (PDF -1MB)
- OGD recently posted online examples of pharmaceutical development reports that exhibit principles of quality by design (QbD) for an immediate release (PDF - 1.5MB) dosage form and a modified release dosage form.
- OGD has updated the Recommendations for Improving Submissions of a “Controlled Correspondence” to the Office of Generic Drugs to provide more detailed information and recommendations about the submission of controlled correspondence. The site had not been updated for several years. We hope that the new information will enhance the value and efficiency of Control Correspondence.
- The Office of Generic Drugs (OGD) recently posted online an example pharmaceutical development report that exhibits principles of quality by design (QbD) for a modified release dosage form (PDF - 2MB). The example is meant to illustrate the types of pharmaceutical development studies abbreviated new drug application (ANDA) applicants may use as they implement QbD in their development process. (February 2012)
- For the submission of Form FDA 3500A reports (15-day Alert Reports and Periodic Adverse Drug Experience Reports) to ANDAs, continue to send these to the following address:
Central Document Room
5901-B Ammendale Road
Beltsville MD 20705-1266
Hours of Operation:
Monday thru Friday 7:00AM - 6:00PM
The new address for all submissions (Abbreviated New Drug Applications (ANDAs), ANDA amendments, ANDA supplements and resubmissions) effective August 1, 2010 is:
Office of Generic Drugs (HFD-600)
Center for Drug Evaluation and Research
Food and Drug Administration
Metro Park North VII
7620 Standish Place
Rockville, MD 20855
Hours of Operation:
Monday thru Friday 7:00AM - 6:00PM
- Determination of Losartan Potassium (Cozaar), and Losartan Potassium and Hydrochlorothiazide (Hyzaar) Exclusivity (PDF - 55KB) (3/26/2010)
- Determination of 180 day Nateglinide Exclusivity (PDF - 90KB) (9/11/2009)
- FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India (2/25/2009)
- Decisions related to PUBLIC LAW 108–173, DEC. 8, 2003, Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003
- Determination of Ganisetron Exclusivity (PDF - 44KB)
- Determination of Ramipril Exclusivity (PDF - 363KB)
- Determination of Acarbose Exclusivity (PDF - 526 KB)
- Determination of Dorzolamide-Timolol Maleate Ophthalmic Solution Exclusivity (PDF - 160KB)
- Determination of Topiramate Sprinkle Capsules Exclusivity (PDF - 83KB)
- Previous News and Announcements
- For first-time generics, see:
- To find all Generic Approvals and Tentative Approvals, you can search Drugs@FDA, using the "Drug Approval Reports by Month" feature. We add new approvals and tentative approvals to Drugs@FDA Reports daily.
On the Drug Approval Reports page, select:
- "Original Abbreviated New Drug Approvals (ANDAs) by Month" for Generic Approvals
- "Tentative Approvals by Month" for Tentative Approvals
- The quarterly List of Authorized Generic Drugs includes the drug trade name, the brand company manufacturer, and the date the authorized generic drug entered the market.
Quality by Design (QbD)/Question based Review (QbR)
- Quality by Design (QbD): An Example Pharmaceutical Development Report for an Immediate Release (IR) Dosage Form (PDF - 1.5MB) (5/2012)
- Quality by Design (QbD): An Example Pharmaceutical Development Report for a Modified Release (MR) Dosage Form (PDF - 2MB) (01/2012)
- Question based Review (QbR) for Chemistry, Manufacturing, and Controls (CMC) evaluation of an Abbreviated New Drug Application (ANDA)
- Question based Review (QbR) for Sterility Assurance evaluation of an Abbreviated New Drug Application (ANDA)
Labeling Question-Based Review (QbR)
- Step-by-step description of how to request an eCTD number from OGD.
- You may request a pre-assigned number, ONLY when you are submitting a NEW eCTD ANDA. If you are converting an established ANDA to eCTD, you MUST use the original ANDA application number.
- If submitting a paper ANDA, do NOT request a pre-assigned number.
If you have any comments or questions, please contact:
Generic Drug Development, Abbreviated New Drug Application (ANDA) Submissions, and Review Information
In Vitro Binding Bioequivalence Study Summary Tables and SAS Transport Formatted Tables for Dataset Submission (PDF - 231KB). The Division of Bioequivalence has developed new data summary tables for in vitro binding bioequivalence studies so that data can be submitted to the Office of Generic Drugs in a concise format consistent with the Common Technical Document. ANDA applicants should complete these tables and send the completed tables along with the rest of the Bioequivalence submission of their ANDA. All the study summary tables should be placed in Module 2, section 2.7. SAS Transport datasets should be placed in Module 5, section 5.3.1. (August 2013)
- The Division of Microbiology has developed a new summary table for Pharmacy Bulk Package Sterility Assurance (PDF - 20KB). This format provides completeness for Pharmacy Bulk Package drug products to address sterility assurance of the drug product associated with the labeling and associated microbiological study data which may be submitted to the application. ANDA applicants submitting applications for Pharmacy Bulk Package drug product should complete this table and submit completed table along with the sterility assurance portion of the CMC section of the ANDA.
- Model Bioequivalence Data Summary Tables (PDF - 219KB) The Division of Bioequivalence has developed new data summary tables so that data can be submitted to the Office of Generic Drugs in a concise format consistent with the Common Technical Document. ANDA applicants should complete these tables and send the completed tables along with the rest of the Bioequivalence submission of their ANDA. All the tables should be placed in Module 2, section 2.7. Recommendations for Improving Submissions of a “Controlled Correspondence” to the Office of Generic Drugs to provide more detailed information and recommendations about the submission of controlled correspondence. (April 2013)
- The Division of Bioequivalence has developed new data summary tables and SAS data tables for the in-vitro data recommended for nasal spray products. This format provides completeness and consistency of the data that will result in a more efficient review of the data. ANDA applicants should complete these tables and send the completed tables along with the rest of the bioequivalence submission of their ANDA. (August 2011)
Bioequivalence Summary Tables For Aqueous Nasal Spray Products (PDF - 1015KB)
SAS Data Tables for Aqueous Nasal Spray Product In Vitro Bioequivalence Study Data Submission (PDF - 97KB)
- ANDA Checklist for Completeness and Acceptability (Quarter 3, 2013) (PDF - 105KB) The Office of Generic Drugs has revised the regulatory filing checklist for 2011 to enhance the ANDA review process. The attached PDF is a copy of the regulatory filing checklist with updates hi-lited in orange (with each posting, the prior posted revision(s) will revert back to black to emphasize the new updates). The regulatory filing checklist will be reviewed on a quarterly basis (calendar year) and updated on an as needed basis. Please contact Johnny Young (johnny.young@FDA.HHS.Gov) and or Iain Margand (Iain.Margand@FDA.HHS.Gov) from the Regulatory Support Branch should you have any questions.
- 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.
- 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.
- Abbreviated New Drug Application Process. This web page includes all the information needed to assist with preparing and submitting ANDAs.
- 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.
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.
Laws Enforced by FDA Code of Federal Regulations (CFR) Federal Register (FR) CDER FOIA Electronic Reading Room
Links to information about advisory committees; clinical investigators; the Division of Drug Marketing, Advertising and Communications correspondence; drug approval packages; and warning letters