PDN HFV to Equi Aid Products Inc Vol by FDADocs


									DEPARTMENT         OF HEALTH   & H      /IAN SERVICES     ;

                                                                               Food and Drug Administration
                                                                               Rockville MD 20857

SP OOP-1486/CP1

*Peter R. Miller DVM, MS
 Equi Aid Products, Inc.
 1517 West Knudsen Drive
 Phoenix, AZ 85027-1307

Dear Dr. Miller:

We refer to your suitability petitio                in which you requested p%nission to
submit an abbreviated new animal                   DA) for a generic product$$at differs
from an approved new animal dru                     form. The approved pion&.r product
referenced in your petition is Mer                 te (ivermectin) which is in%&ded for
use in horses, including mares, ye,                  eeks of age and older     lxx+;*
(NADA 134-314).                                                                 s*
We informed you by telephone on nuary 11,2001, th    e letter faxed to you on
December 27,2000, approving yo petition was inadve    tly released before the Center’s
review of the petition was comple We have now co     ted our evaluation of your petition
and this letter is my ruling on it.

Your proposed product differs fro:                                      and dosage form. The
pioneer product is an oral paste, w                                      packet containing five
chewables that are administered v                             sing or mixing in a small amount 0.f
feed. The dosage of active ingred ier                         eight will be the same.

Changes in strength and dosage                                e pioneer ,product.which can be
considered through a suitability                              (n)(3) of the Federal Food, Drug, and
Cosmetic Act. Pursuant to that pro                               approve a petition for a new animal
drug intended for use in a                                      ine that investigations must be
conducted to show the                                                in the proposed generic

We have concluded that your                                    ied because studies must be
conducted to show the                                               in horses. Unlike the pioneer
product, the proposed                                                                                         I
                                                                     nd-feeding, top-dressing, or
mixing in a small amount of feed.         are concerned tha     1smay not consume an adequate                 I,
                                                                 feeding to get effective treatment.

However, you may wish to submit a                                  bed in our Seventh GADPTRA                 I
                                                                     s of an ANADA and an
                                                                   on the product for which the
SP OOP-1486KP1

application is submitted and                               : study and any additional studies
required for approval of the                               commend that you arrange a meeting
with us to discuss the studies we                           and that you submit protocols for our
review before initiating any in vivc

If you disagree with our denial of                          you may petition for reconsideration
of the denial following the                                 10.33. Such petition should be
submitted in accordance                                    :d in 0 10.33. The petition must be
based solely on the information                            ur original petition. The petition for
reconsideration should be submit       o later than 30     after the date of this denial of the
suitability petition and must be ti    rith the Dockets    xagementBranch, Food and Drug
Administration, HFA-305, 5630                              Lockville, MD 20852. Pleaserefer to
docket number OOP-1486in any                                original suitability petition.

If there is additional information                         tur original submission that you would
like the agency to consider, you                           ion under $ 10.30 and include all
necessaryinformation to the Dot                            Lat the address noted above.

This action in response to your suit   lity petition does 1 t alter the requirements for approval of
a new animal drug, nor assureappr      11 the new anim drug.

If you have any questions regarding is letter, please ca’ Dr. Allen Rudman, Deputy Director,
Office of New Animal Drug Evalua In, (301) 827-0204

                                                           xxely yours,

                                                           reM.   Lathers, Ph.D., F.C.P.    .
                                                           ‘ce ofNew Animal Drug Evaluation
                                                           i1er for Veterinary Medicine
                                                                       DA Suitability Petition section in
                                                                        Animal’ Drug and Patent Term
1)    Specifically the Pre-A.NADA Activities,
      letter ‘states:
         “The filing of a Suitability Petition pr                      ‘a firm may request permission to
         file an &IADA for a product which
         The specific variances under the Act                          ition may be submitted are as

         2.   Change of a dosage form
         3.   Change of a strength of an ingr
         4.   Change in route of-administrati
         5.   Change in use with other animal       in animal feed.”

      Equi Aid is requesting permission to file                        rs from the pioneer in that the
      pioneer is a paste oral dosage form                                    and the proposed ,product
      product would.:difier ,containing
      would be a chewabie in.dosage:form;                                       Thus the proposed

      The proposed generic product would co ‘tain animal feeds s inactive ingredients and would
      be administered via hand feeding, top-dr ss on feed or by ixing in the horses grain ration.
                                              FI               t-7

      Peter R. Miller DVM MS

                                                                                            623+92&385     (FAX)

      MEMO                 DEPARTMEI
                                             LIC HEALTH SE

     DATE:           7/26/01

     FROM:           Animal Scientist
                     Quality Assuranc Support Staff ,          1102

     SUBJECT:        Suitability Petitic   Response for Disp

     TO:            Lyle Jaffe, HFA-: 15,5630 Fishers L            r-m. 106 1, Rockville, MD
                    Dockets Manage                                                         *g

     The attachment is the Center for d                                 related to Suitability
     Petition SP OOP-1486CP 1, submitt                                      filed as a Suitability
     Petition. We are forwarding a coy

     If you have any questions, please c      me at 827-0211, 1 FAX 827-43 17.

     Thank you.


     Samuel Hansard, Ph.D.
     7500 Standish Place MPN II 384
     Rockville, MD 20855
     (301) 827-0211
     (301) 827-43 17 fax

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