Food and Drug Administration, HHS.
This notice announces the availability of draft guidances for industry that describe recommendations on how to design bioequivalence (BE) studies for 200 specific drug products to support abbreviated new drug applications (ANDAs). These draft guidances are being made available Start Printed Page 30387concurrently with the publication of a draft guidance for industry entitled “Draft Guidance for Industry—Bioequivalence Recommendations for Specific Products” (product specific BE recommendations). This draft guidance describes the new process for making available guidance on product-specific BE studies. Under the process described in the draft guidance, draft and final product-specific BE study guidance will be made available on the FDA Web site. FDA believes that making this information available on the Internet will streamline the guidance process and provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a related guidance document entitled “Draft Guidance for Industry—Bioequivalence Recommendations for Specific Products.”
Submit written or electronic comments on the draft guidances by September 28, 2007. General comments on agency guidance documents are welcome at any time.
Submit written requests for single copies of draft product-specific BE study guidances to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Doan T. Nguyen, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0495.End Further Info End Preamble Start Supplemental Information
To receive approval for an ANDA, an applicant generally must demonstrate, among other things, that its product has the same active ingredient, dosage form, strength, route of administration and conditions of use as the listed drug, and that the proposed drug product is bioequivalent to the reference listed drug (21 U.S.C. 355(j)(2)(A); 21 CFR 314.94(a)). Bioequivalent drug products show no significant difference in the rate and extent of absorption of the therapeutic ingredient (21 U.S.C. 355(j)(8); 21 CFR 320.1(e)). BE studies are undertaken in support of ANDA submissions with the goal of demonstrating BE between a proposed generic drug product and its reference listed drug. The regulations governing BE are provided at 21 CFR in part 320.
The draft guidance entitled “Bioequivalence Recommendations for Specific Products” describes the following process for making available draft and final product-specific BE recommendations:
- FDA will develop product-specific BE recommendations and post them on the Center for Drug Evaluation and Research (CDER) guidance page (http://www.fda.gov/cder/index.html) in draft to facilitate public consideration and comment. The recommendations can be viewed by clicking on the URL associated with the “Bioequivalence Recommendations for Specific Products” guidance on the CDER guidance page or on the Office of Generic Drugs Page (see www.fda.gov/cder/ogd/index.htm). Users can also search for a specific product BE recommendation using the search tool on the CDER guidance page.
- Newly posted draft and final BE recommendations will be announced in the “Newly Added Guidance Documents” list, which is posted monthly on the CDER guidance page.
- The agency will issue a notice in the Federal Register announcing the availability on the FDA web site of new product-specific draft and final BE recommendations. The notice will identify a comment period for the recommendations.
- Comments on product-specific BE recommendations will be considered in developing final BE recommendations.
- The BE recommendations will be revised as appropriate to ensure that the most up-to-date BE information is available to the public.
FDA is making the first group of draft product-specific BE recommendations available concurrently with the issuance of the draft guidance document describing the process.
II. Drug Products for Which Draft Product-Specific BE Recommendations Are Available
The FDA is making available draft recommendations for drug products containing the following active ingredients:
|Abacavir Sulfate; Lamivudine; Zidovudine|
|Amlodipine Besylate; Benazepril HCl|
|Amoxicillin; Clavulanate Potassium|
|Bisoprolol Fumarate; Hydrochlorothiazide|
|Candesartan Cilexetil; Hydrochlorothiazide|
|Carbidopa; Entacapone; Levodopa|
|Diclofenac Sodium; Misoprostol|
|Didanosine (multiple dosage forms)|
|Duloxetine HCl (multiple dosage forms)|
|Efavirenz (multiple dosage forms)|
|Famotidine (multiple dosage forms)|
|Felbamate (multiple dosage forms)|
|Fexofenadine HCl (multiple dosage forms)|
|Fluoxetine HCl; Olanzapine|
|Start Printed Page 30388|
|Fosinopril Sodium; Hydrochlorothiazide|
|Gabapentin (multiple dosage forms)|
|Glipizide; Metformin HCl|
|Glyburide; Metformin HCl|
|Hydrochlorothiazide; Losartan Potassium|
|Hydrochlorothiazide; Moexipril HCl|
|Hydrochlorothiazide; Olmesartan Medoxomil|
|Ibuprofen; Pseudoephedrine HCl|
|Isradipine (multiple dosage forms)|
|Lamotrigine (multiple dosage forms)|
|Meloxicam (multiple dosage forms)|
|Metformin HCl; Pioglitazone HCl|
|Mycophenolate Mofetil HCl|
|Omeprazole (multiple dosage forms)|
|Ondansetron (multiple dosage forms)|
|Oxcarbazepine (multiple dosage forms)|
|Ribavirin (multiple dosage forms)|
|Risedronate Sodium; Calcium Chloride|
|Topiramate (multiple dosage forms)|
|Tramadol HCl; Acetaminophen|
|Verapamil HCl (multiple dosage forms)|
|Zidovudine (multiple dosage forms)|
These draft guidances are available on the CDER guidance page and may be viewed by clicking on the URL associated with the draft “Bioequivalence Recommendations for Specific Products” guidance on the CDER guidance page or on the Office of Generic Drugs Page (see www.fda.gov/cder/ogd/index.htm). Users can also search for a specific product BE recommendation using the search tool on the CDER guidance page.
These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidances represent the agency's current thinking on the design of product-specific bioequivalence studies to support ANDAs. Guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidance. Two copies of mailed comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the draft product-specific BE recommendations at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.Start Signature
Dated: May 22, 2007.
Assistant Commissioner for Policy.
[FR Doc. E7-10491 Filed 5-30-07; 8:45 am]
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