Generic Drugs: Information for Industry

• Generic Drug User Fee; Public Meeting September 17, 2010; Request for Comments  (9/8/2010)

• 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

• 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:
  • ANDA (Generic) Drug Approvals and
  • ANDA (Generic) Drug Approvals - Previous Years .
• 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.

• 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:
  Gerrard Cuthbert
  E-mail: gerrard.cuthbert@fda.hhs.gov
  301-796-3981

•   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. There are instructions with the tables explaining how to fill them out. Common Technical Document (CTD) Modules/Sections Corresponding to Summary Data Tables in Bioequivalence Submissions to ANDAs .
• The Division of Bioequivalence has developed new data summary 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. Bioequivalence Summary Tables For Aqueous Nasal Spray Products [PDF - 1015KB]
• ANDA Checklist for Completeness and Acceptability [ PDF ] Note: In Sections 3.2.S.2.1 and 3.2.P.3.1, it is critically important that the correct Name, Full Address and establishment contact information of the manufacturing or testing facility location be included (not the corporate address). Additionally, the correct FDA Establishment Identifier number (FEI) or Central File Number (CFN) for the exact facility must be included.
• 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.

• Suitability Tracking Reports

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.