Get documents about "PDN HFV to Equi Aid Products Inc Vol
Document Sample
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+;*
r”a
..M
(NADA 134-314). s*
$22
CD
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
product.
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
Page2
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.
of
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. .
1
ctor
‘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,
I
letter ‘states:
1..
“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)
1’
MEMO DEPARTMEI
LIC HEALTH SE
FOOI
CENT
II
IIi
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
i--J
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.
Attachment
Samuel Hansard, Ph.D.
FDA/CVM/ONADEIQASSIV-102
7500 Standish Place MPN II 384
Rockville, MD 20855
(301) 827-0211
(301) 827-43 17 fax
shansard@cvm.fda.gov
Related docs
Other docs by FDADocs
