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Veterinary Drugs

 
Product and
NADA/ANADA Number
Trade Name
Ingredients
trimethoprim/sulfadiazine
200-033
Uniprim Powder
trimethoprim/sulfadiazine

                                                                   
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Summary of 
FDA Information:

FOI Summary; NADA 200-033 (original); Uniprim Powder (trimethoprim/sulfadiazine); original; June 11, 1993 --Editor's abstract FREEDOM OF INFORMATION SUMMARY 1. GENERAL INFORMATION: ANADA Number: 200-033 Sponsor: Macleod Pharmaceuticals, Inc. 2600 Canton Court Fort Collins, CO 80525 Trade Name: Uniprim Powder Generic Name: Trimethoprim/Sulfadiazine Dosage Form: Powder How Supplied: 37.5 g packets How Dispensed: Rx Amount of
Active Ingredients: Trimethoprim, 67 mg/g; Sulfadiazine, 333 mg/g Route of
Administration: Oral Species: Horses Labeled Dosage: 3.75 g per 110 lbs body weight per day Indications for
Use: For control of
bacterial infections of
horses during treatment of
acute strangles, respiratory tract infections, acute urogenital infections, wound infections and
abscesses. Pioneer Product: Tribrissen 400 Oral Paste (TMP/SDZ), Coopers Animal Health Inc., NADA 131 -918. Date Stamped: June 11, 1993 2. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS: 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 a clinical end-point study
in food animals, 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
(55 FR 24645, June 18,1990; Fifth GADPTRA Policy Letter; Bioequivalence Guideline, April 1990). Bioequivalence Study: Based on the formulation characteristics of
the generic product, Dr. Mary Kiter, Colorado State University, College of
Veterinary Medicine, and

Dr. Dave Wheeler, Kerr Farms, Fort Collins, Colorado, generated the data of
the in vivo bioequivalence study
with Uniprim Powder (trimethoprim/ sulfadiazine) and
Tribrissen Paste.
The generic and
pioneer products are powder and
paste, respectively, with the same active ingredients.
A total of
twenty-four horses were
randomly assigned between two groups (12 horses/group). Using a two-period crossover experimental design, one group of
horses in period one was
administered the generic formulation, and

the second group of
horses was
given the pioneer product. Following a washout period, the
horse groups were
given the opposite treatments. Both products were
administered at dosage rates of
30 mg/kg of
body weight in each of
the two test periods. During a 24-hour period, blood samples were
collected from
each horse predose and
at 17 post-treatment intervals in each period (0.5,1,1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8,10,12,14,18, and

24 hours).
The blood samples were
centrifuged, and

the serum was
drawn off and
frozen.
The serum samples from
"0" hour through 24 hours were
subsequently assayed for
trimethoprim and
sulfadiazine using HPLC analysis.
The data of
the serum assays are summarized in the
tables below.
The data were
statistically analyzed with an analysis of
variance procedure, following the Bioequivalence Guideline issued by the Center for
Veterinary Medicine (FDA), April 12, 1990. (Eds. note: The following 2 tables consist of
5 columns each.) Sulfadiazine Data: Variable Uniprim Tribrissen Lower Upper AUC 202.3590 191.6030 -0.8276% 12.0560% AUMC 1582.1500 1567.8200 -6.8751% 8.7020% Cmax 22.3916 19.3372 7.4720% 24.1190% Tmax 3.8125 4.1458 -20.4590% 4.4686% MRT 7.7455 8.1057 -7.6310% -1.2550% AUC = area under
the curve Tmax = time to maximum concentration AUMC = area under
the moment curve MRT = mean residence time Cmax = maximum concentration -------------------------------------------------------------------------------- Trimethoprim Data: Variable Uniprim Tribrissen Lower Upper AUC 5.0273 4.9824 -8.6755% 10.4766% AUMC 23.7278 22.5880 -9.2344% 19.3234% Cmax 1.0337 1.0609 -14.5644% 9.4440% Tmax 2.2500 1.7917 -3.9950% 55.1580% MRT 4.6700 4.2930 0.8880% 16.6830% AUC = area under
the curve Tmax = time to maximum concentration AUMC = area under
the moment curve MRT = mean residence time Cmax = maximum concentration -------------------------------------------------------------------------------- The above parameters were
analyzed using 90% confidence intervals. Two of
the sulfadiazine parameters (Tmax and
Cmax) did not have their confidence intervals, based on the difference between test and
reference product means, within 20% of
their reference means.
The other three parameters have their confidence intervals, based on the difference between means, within 20% of
their reference means. Previously, bioequivalence of
drug products were
based on AUC, Cmax, and

Tmax. However, due to the difficulty of
accurately determining Tmax and
Cmax, the
bioequivalence of
two products are currently determined by the parameters AUC, AUMC, and

MRT (Bioequivalence Guideline, April 12, 1990). Only one of
the trimethoprim parameters (Tmax) did not have its confidence interval, based on the difference between test and
reference product means, within 20% of
its reference mean.
The other four parameters have their confidence intervals within 20% of
their reference means.
The results above are given with Lower = (L/mean of
X sub R)*100% and
Upper = (U/mean of
X sub R)*100%. L= lower bound on the 90% confidence interval, and

U = upper bound on the 90% confidence interval for
the difference between the test and
pioneer product means.
The results of
this study
are adequate to demonstrate bioequivalence between the test product and
the reference product. Palatability Study: The palatability study
was conducted by Dr. Dave Wheeler, Kerr Farms, Fort Collins, Colorado. Ten horses were
divided into
two groups of
five horses each. Group A was
fed 2.5 lbs of
grain containing the normal dose of
Uniprim Powder (37.5 g) once per day for
five consecutive days. Group B horses were
fed 2.5 lbs of
unmedicated grain once daily for
five consecutive days.
The two groups were
then crossed over and
the study
continued for
another 5 days. At each feeding, the
amount of
grain consumed and
the time taken to consume the grain were
recorded. Essentially, all of
the grain was
consumed at each feeding by both groups.
The average consumption time was
10 minutes for
horses receiving the unmedicated grain and
12.5 minutes for
horses given the medicated grain. No aversion to the medicated feed developed over the five day course of
treatment.
The horses consistently ate all of
the medicated feed. 3. HUMAN FOOD SAFETY: The drug is labeled: "Not for
use in horses intended for
food." Data on Human food safety were
not required for
approval of this Abbreviated New Animal Drug Application. 4. AGENCY CONCLUSIONS: This ANADA satisfies the requirements of
section 512 of
the Act and
demonstrates that Uniprim Powder (trimethoprim/sulfadiazine), when
used under
its proposed conditions of
use, is safe and
effective for
its labeled indications. For the safe and
effective use of
Uniprim Powder, it is necessary to provide a diagnosis of
acute strangles, respiratory tract infections, acute urogenital infections and
to treat wound infections and
abscesses. Accordingly, we have classified Uniprim Powder as a prescription item. 5. LABELING: Uniprim(TM) Powder product label Uniprim(TM) Powder package insert Tribrissen® 400 Oral Paste carton label Tribrissen® 400 Oral Paste product label Tribrissen® 400 Oral Paste package insert Copies of
these 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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