Summary of
FDA Information:
Approval Date: August 1, 1998
Freedom of
Information Summary
NADA 141-035
I. GENERAL INFORMATION:
NADA 141-035
Sponsor: Novartis Animal Health US, Inc.
Post Office Box 26402
Greensboro, NC 27404
Generic Name: Lufenuron Tablets
Trade Name: PROGRAMā Flavor Tabsä
Marketing Status: Over-The-Counter
Effect of
Supplement:
Approval of
this supplemental NADA will change NADA 141-035 by adding a flavored tablet formulation with the same indications as the non-flavored tablets.
II. INDICATIONS FOR USE
PROGRAM Flavor Tabs are indicated for
use in dogs and
puppies six weeks of
age and
older for
the prevention and
control of
flea populations and
in cats and
kittens, six weeks of
age and
older for
the control of
flea populations. Lufenuron controls flea populations by preventing the development of
flea eggs and
does not kill adult fleas. Concurrent use of
insecticides may be necessary for
adequate control of
adult fleas.
III. DOSAGE FORM, ROUTE OF ADMINISTRATION AND RECOMMENDED DOSAGE
For Use in Dogs: PROGRAM Flavor Tabs are given orally, once a month, at the
recommended minimum dosage of
4.5 mg/lb (10 mg/kg).
Recommended Dosage Schedule for
Dogs
Body Weight
Lufenuron Per Tablet
Up to 10 lbs.
45 mg
11 - 20 lbs.
90 mg
21 - 45 lbs.
204.9 mg
46 - 90 lbs.
409.8 mg
Dogs over 90 lbs. are provided the appropriate combination of
tablets.
For Use in Cats: PROGRAM Flavor Tabs are given orally, once a month, at the
recommended minimum dosage of
13.6 mg/lb (30 mg/kg).
Recommended Dosage Schedule for
Cats
Body Weight
Lufenuron Per Tablet
Up to 6 lbs.
90 mg
7 - 15 lbs.
204.9 mg
Cats over 15 lbs. are provided the appropriate combination of
tablets.
IV. EFFECTIVENESS
The effectiveness of
PROGRAMā Flavor Tabsä is based upon existing Novartis product approvals for
lufenuron (PROGRAMā Tablets, NADA 141-035, PROGRAMā Suspension, NADA 141-026).
The flavoring agent used in this formulation has been adequately tested for
palatability in existing Novartis product approvals (PROGRAMā Cat Flavor Tablets, NADA 141-062, SENTINELā Flavor Tablets, NADA 141-084).
V. ANIMAL SAFETY
The safety of
PROGRAM Flavor Tabs is based upon existing Novartis product approvals for
lufenuron (PROGRAM Tablets, NADA 141-035, PROGRAM Suspension, NADA 141-026).
VI. HUMAN FOOD SAFETY
Data on human safety, pertaining to consumption of
drug residues in food, were
not required for
approval of this NADA.
This drug is to be labeled for
use in dogs and
cats which
are non-food animals.
VII. AGENCY CONCLUSIONS:
The data in support of
this NADA comply with the requirements of
Section 512 of
the Act and
Part 514 of
the implementing regulations.
The data demonstrate that PROGRAM Flavor Tabs (lufenuron), when
used under
labeled conditions of
use, are safe and
effective.
Because adequate directions for
the safe and
effective lay use of
PROGRAM Flavor Tabs could be written, the
product has been labeled for
over-the-counter distribution.
Under section 512(c)(2)(F)(iii) of
the FFDCA, this approval for
non food producing animals does not qualify for
marketing exclusivity because the supplemental application does not contain substantial evidence of
the effectiveness of
the drug involved, or
any studies of
animal safety required for
the approval and
conducted or
sponsored by the applicant.
Patent # 5,416,102 expires May 2012; Patent # 5,420,163 expires May 2012; Patent # 4,798,837 expires January 2006.
VIII. LABELING (Attached)
A. Package Inserts--canine, feline
B. Blister Foils--45 mg, 90 mg, 204.9 mg, 409.8 mg
C. Unit Dose Cartons--45 mg, 90 mg, 204.9 mg, 409.8 mg
D. Display Cartons--45 mg, 90 mg, 204.9 mg, 409.8 mg
E. Shipper Cartons--45 mg, 90 mg, 204.9 mg, 409.8 mg
F. Reminder Stickers
Copies of
applicable labels may be obtained by writing to the:
Freedom of
Information Office
Center for
Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855
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