FDA is announcing revised draft product-specific BE recommendations for drug products containing the following active ingredients:
Hydrochlorothiazide; losartan potassium
Phytonadione (multiple RLDs and dosage forms)
Theophylline (multiple RLDs)
For a complete history of previously publishedFederal Registernotices related to product-specific BE recommendations, please go tohttp://www.regulations.govand enter docket number FDA-2007-D-0369.
These draft and revised draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These guidances represent the Agency's current thinking on product-specific design of BE studies to support ANDAs. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. Analternative 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 (seeADDRESSES) either electronic or written comments on any of the specific BE recommendations posted on FDA's Web site. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. The guidances, notices, and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet may obtain the document at eitherhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: September 4, 2012.
Assistant Commissioner for Policy.