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1、Section 7.0 - Suitability Petition ActionNumberPetitionerDescriptionActionDate89P-0191/CP1Fermenta Animal Health Co.Request to substitute sulfathiazole for sulfamethazine in a Type A medicated feed article for use in feed for beef cattle.DeniedJuly 198989P-0191/PRCFermenta Animal Health Co.Request t
2、o reconsider proposal to substitute sulfathiazole for sulfamethazine in a Type A medicated feed article for use in feed for beef cattle.DeniedDecember 198989P-0446/CP1Boehringer Ingelheim Vetmedica, Inc.Request to differ the dosage form and strength in a Type A medicated feed article.ApprovedDecembe
3、r 198989P-0509/CP1Cheminex Laboratories, Inc.Request to change dosage form in NADA 131-918 (Tribrissen 400 Oral Paste) from paste to a powder mixed with feed.ApprovedJanuary 199090P-0051/CP1Beecham LaboratoriesRequest to change Nemex Tabs from two tablet strengths, 22.7 and 113.5 milligrams per tabl
4、et to four tablet strengths, 22.7, 45.4, 90.8, and 136.2 milligrams per tablet.ApprovedMarch 199090P-0073/CP1A. L. LaboratoriesRequest to revoke approval of petition 89P-0446/CP approved in 1989 for Boehringer Ingelheim Animal Health, Inc.DeniedApril 199090P-0181/CP1American Cyanamid, Division AHP C
5、orp.Request permission to file ANADA for change of dosage form of CSP500 and CSP250 Type A medicated feed articles containing chlortetracycline, sulfathiazole and penicillin.ApprovedJuly 199090P-0213/CP1Micrel Limited, Inc.Request permission to file an ANADA containing a change in dosage form to pro
6、vide microencapsulation (microspheres) of the active ingredient in an injectable form of RALGRO (NADA 038-233).DeniedAugust 199090P-0213/PRCMicrel Limited, Inc.Request reconsideration to file an ANADA containing a change in dosage form to provide microencapsulation (microspheres) of the active ingre
7、dient in an injectable form of RALGRO (NADA 038-233).DeniedOctober 199090P-0434/CP1Sanofi Animal Health, Inc.Request permission to substitute a different salt form of one active ingredient in a lincomycin spectinomycin combination. Pioneer product is NADA 046-109.ApprovedFebruary 199191P-0048/CP1San
8、ofi Animal Health, Inc.Request permission to change the dosage form for Sulfaquinoxaline sodium solution. The pioneer NADA is 006-677.AcknowledMarch 1991Sanofi Animal Health, Inc.DeniedMarch 1991FDA APPROVED PRODUCTJanuary 2014Section 7.0 Suitability Petition Actions Page 1 of 30NumberPetitionerDesc
9、riptionActionDate91P-0071/CP1Fermenta Animal Health Co.Request permission to change strength of oxytetracycline in a generic product referencing NADA 113-232. *Note: The original approval of this petition was revised to require labeling changes of the generic product to be consistent with that of th
10、e pioneer product. See 91P-0285/CP1 for details.AcknowledJune 1992Fermenta Animal Health Co.ApprovedDecember 199191P-0255/CP1Sanofi Animal HealthRequest permission to file an ANADA for an oral dosage form for neomycin solution in place of the pioneers soluble powder form. The pioneer product is NADA
11、 011-315.ApprovedAugust 199291P-0277/CP1The Upjohn Co.Request permission to file an ANADA for a different dosage form of neomycin soluble powder. The pioneer product is NADA 011-315. *The petition was approved but the applicant may not file an ANADA until the pioneer product has been DESI finalized
12、and approved.Approved*September 1991The Upjohn Co.Approved*September 1992FDA APPROVED PRODUCTJanuary 2014Section 7.0 Suitability Petition Actions Page 2 of 30NumberPetitionerDescriptionActionDate91P-0285/CP1Pfizer, Inc.Request that FDA require bioequivalence testing of generic oxytetracycline animal
13、 drug products referencing Pfizers Liquamycin LA-200. The petition also requested that FDA deny Fermenta Animal Health Companys ANADA for an oxytetracycline product. Pfizer pointed out that the Fermenta ANADA does not contain tissue residue studies for calculation of a withdrawal period. *Note: Six
14、points raised in the petition were addressed. The Agency agreed that demonstration of in vivo bioequivalence between the Fermenta and Pfizer formulations is essential to the approval of Fermentas ANADA. The Agency did not agree that tissue residue studies necessarily would be required. The pharmacok
15、inetic profiles of both formulations will be evaluated to determine bioequivalence and could be used in lieu of a tissue residue study in assigning a withdrawal period. The Agency agreed that bioequivalence studies would be required in more than one species but it does not intend to require demonstr
16、ation of bioequivalence in all classes of animals within a species. Bioequivalence studies in the Fermenta ANADA will be required in swine and in one class of adult ruminating nonlacting cattle. The Agency agreed that the Fermenta product, although a different strength, must be labeled to deliver the same dose of oxytetracycline base to the animal. The Agency retracted a statement made in approving the Fermenta suitabili
