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CVM FOI…
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FOI Summary; ANADA 200-223 (original); Albac®50 (bacitracin zinc); August 20, 1997
Freedom of Information Summary 1. GENERAL INFORMATION: Hybrid Application (refer to Agency Conclusions section at the end of the FOI Summary): This approval is based upon a determination of bioequivalence, as required by Section 512(b)(2), and additional safety and effectiveness data, as required by Section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act. ANADA Number: 200-223 Sponsor: Alpharma, Inc. Generic Name: Bacitracin zinc Trade Name: ALBAC® 50 Marketing Status: OTC Pioneer Product: BACIFERM® (bacitracin zinc) Type A Medicated Article; NADA 46-920; Hoffmann-La Roche 2. INDICATIONS FOR USE This original hybrid ANADA provides for use in feedlot cattle for increased rate of weight gain and improved feed efficiency based on a showing of bioequivalence to the pioneer product BACIFERM in addition to chicken, turkey, pheasant, quail and swine claims currently approved for ALBAC 50 under NADA 98-452 and/or BACIFERM. 3. PRODUCT INFORMATION A. Dosage Form: Type A Medicated Article B. Route of Administration: Administer orally by adding the Type A medicated article to complete chicken, turkey, pheasant, quail, swine and cattle feed (Type C medicated feed). C. Recommended Dosage: Chickens, turkeys and pheasants: 4-50 g/ton 4. EFFECTIVENESS AND TARGET ANIMAL SAFETY Approval of the additional claim for ALBAC is based on the terms of the Generic Animal Drug and Patent Term Restoration Act and supporting information contained in NADA 98-452 for the claims which differ from those of the pioneer. Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act, (53 FR 50460, December 15, 1988, First GADPTRA Policy Letter) an abbreviated new animal drug application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). New target animal safety data, drug effectiveness data, and human food safety data (other than tissue residue data) are not required for approval of an ANADA. An ANADA relies on the target animal safety, drug effectiveness, and human food safety data in the pioneer's new animal drug application. Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through an in vivo study, then a tissue residue study to establish the withdrawal time for the generic product is also required. For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (61 FR 26182, May 24, 1996; Bioequivalence Guideline). In accordance with the Center's seventh GADPTRA Policy Letter dated March 20, 1991, a generic applicant may submit a 512(b)(1) application for a change in an already approved drug that requires the submission and review of investigations conducted by or for the applicant, without first obtaining approval of an ANADA for a duplicate of the listed animal drug. Such data for the ALBAC 50 claims (laying chickens and growing-finishing swine) which differ from the pioneer claims have been approved under 512(b)(1) of the Act and are incorporated by reference to NADA 98-452. The approval for the layer claim was published at 46 FR 21363, April 10, 1981; and the swine claim was published at 46 FR 61073, December 15, 1981. Alpharma, Inc. was granted a waiver from conducting an in vivo bioequivalence study for bacitracin zinc as a Type A medicated article. The bioequivalence of the pioneer and generic products was considered to be self-evident, because the active ingredient used in both Type A medicated articles is from the same source (manufacturer). 5. HUMAN SAFETY A. Tolerances: The tolerances established for the pioneer product apply to the generic product. A tolerance of 0.5 ppm (0.02 unit per gram) is established for edible tissues of cattle and in milk (21 CFR 556.70). The generic product will also bear claims for chickens, turkeys, pheasants, quail, and swine by reference to approved NADA 98-452. A tolerance of 0.5 ppm (0.02 unit per gram) is established for edible tissues for chickens, turkeys, pheasants, quail, swine, and in eggs for those claims referenced under NADA 98-452 (21 CFR 556.70). B. Withdrawal Time: When a waiver from the requirement of an in vivo bioequivalence is granted, the withdrawal period assigned to the generic product is the same as that previously assigned to the pioneer. A zero withdrawal is established for bacitracin zinc in cattle under 21 CFR 558.78. The generic product will also bear claims for chickens, turkeys, pheasants, quail, and swine by reference to approved NADA 98-452. A zero withdrawal is established for bacitracin zinc in chickens, turkeys, pheasants, quail, and swine under 21 CFR 558.78. C. Regulatory Method for Residues: An analytical method for microbiologically active residues of bacitracin zinc in tissues is described in the following reports: 1) "Antibiotic Residue in Milk, Dairy Products and Animal Tissues: Methods, Reports, Protocols," National Center for Antibiotic Analyses, Dept. HEW Washington DC 20204, Rev. October 1968; and 2) "Modified Microbiological Method for Determination of Bacitracin in Tissues," Alpharma, Inc., One Executive Drive, Fort Lee, NJ 07024.
The information submitted in support of this hybrid application satisfy the requirements of Section 512(b)(1) and 512 (b)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 514 of the regulations. The hybrid application has been defined in the Center's Seventh Generic Animal Drug Policy Letter, dated March 20, 1991. An applicant may seek approval of a modification of a listed animal drug that requires the review of investigations. The statute could be interpreted to require such an applicant to first obtain approval of an ANADA for the listed animal drug's approved product, and then file a 512(b)(1) supplement to the approved ANADA containing clinical data to obtain approval of the modification. If the applicant did not first obtain an ANADA for the approved product, the applicant could be required to submit a full new animal drug application (NADA) under section 512(b)(1) of the act for the modification and duplicate the basic safety and effectiveness studies conducted on the listed animal drug. The agency has concluded that such an interpretation would be inconsistent with the legislative purposes of the 1988 Amendments because it would serve as a disincentive to innovation and would require needless duplication of research. The agency believes that a more consistent, less burdensome interpretation of the 1988 Amendments is to allow a generic applicant to submit a 512(b)(1) application for a change in an already approved animal drug that requires the submission and review of investigations conducted by or for the applicant, without first obtaining approval of an ANADA for a duplicate of the listed animal drug. Therefore, the agency accepts applications for changes requiring the review of investigations conducted by or for the applicant. These applications are known as "hybrid" applications. Like similar supplements to approved ANADA's, these applications rely on the approval of the listed animal drug, together with the data needed to support the change. The data submitted in support of this hybrid application demonstrate that ALBAC® (bacitracin zinc), when used under its proposed conditions of use, is safe and effective for its labeled indications. The hybrid application provides for different label indications between the generic (ALBAC®) and the pioneer product (BACIFERM®), by providing for unique label claims for laying chickens (10-25 g/ton for increased egg production and improved feed efficiency) and growing-finishing swine (10-50 g/ton for increased rate of weight gain and improved feed efficiency).
The hybrid application relies on the approval of a listed (pioneer) animal
drug, and contains additional data needed to support the change in the generic
product. The hybrid applicant is thus relying on the approval of the listed
animal drug to the extent that such reliance is allowed under section 512(n) of
the act, to establish the safety and effectiveness of the underlying animal
drug. An application that relies in part on the approval of a listed animal
drug, is, for this purpose, considered an application described in section
512(b)(2). A patent number does not apply to this product. The tolerances established for the pioneer product apply to the generic product. A tolerance of 0.5 ppm (0.02 unit per gram) is established for edible tissues of cattle and in milk (21 CFR 556.70). The hybrid product will also bear claims for chickens, turkeys, pheasants, quail, and swine by reference to approved NADA 98-452. A tolerance of 0.5 ppm (0.02 unit per gram) is established for edible tissues for chickens, turkeys, pheasants, quail, swine, and in eggs for those claims referenced under NADA 98-452 (21 CFR 556.70). When a waiver from the requirement of an in vivo bioequivalence is granted, the withdrawal period assigned to the generic product is the same as that previously assigned to the pioneer. A zero withdrawal is established for bacitracin zinc in cattle under 21 CFR 558.78. The hybrid product will also bear claims for chickens, turkeys, pheasants, quail, and swine by reference to approved NADA 98-452. A zero withdrawal is established for bacitracin zinc in chickens, turkeys, pheasants, quail, and swine under 21 CFR 558.78. Attachments: Facsimile Generic Labeling and Currently Approved Pioneer Labeling are attached, as shown:
---Type A article labeling for BACIFERM50 (pioneer)
Copies of applicable labels may be obtained by writing to the:
Freedom of Information Office
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