Betterchem
Health     Drug Information     News     FindingHealthOnline     For Industry     Search     Site Map

 


Veterinary Drugs

 
Product and
NADA/ANADA Number
Trade Name
Ingredients
penicillin G benzathine and
penicillin G procaine.
065-506
Combicillin; or
Combicillin-AG ;
penicillin G benzathine and
penicillin G procaine.
penicillin G potassium
200-106
R-Pen
penicillin G potassium
200-122
Solu-Pen
Penicillin G Potassium
penicillin G potassium, USP
200-103
Penicillin G Potassium, USP
penicillin G potassium, USP
penicillin G procaine
065-505
Microcillin-AG ; ;
penicillin G procaine

                                                                   
Back to TOC


API Locator: A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z

Home | Drug Thesaurus | Veterinary Master Files | Version with API Search | Services | Site Map

Summary of 
FDA Information:

Approval Date: November 8, 1993 Freedom of
Information Summary NADA 065-506 I. GENERAL INFORMATION: NADA 065-506 Sponsor: Anthony Products Co. 5600 Peck Road Arcadia, CA 91006 Generic Name: Penicillin G Benzathine Penicillin G Procaine. Trade Name: Combicillin Combicillin-AG Marketing Status: OTC: Combicillin-AG Rx: Combicillin II. INDICATIONS FOR USE The prescription product, Combicillin is indicated for
use in beef cattle, in horses, and

in dogs for
bacterial infections due to the following microorganisms that are susceptible to the serum levels of
penicillin common to this particular dosage form: Pneumonia (shipping fever complex) caused by Streptococcus spp., Corynebacterium pyogenes, Staphylococcus aureus; Upper respiratory infections such as rhinitis or
pharyngitis caused by Corynebacterium pyogenes; Equine strangles caused by Streptococcus equi; Blackleg caused by Clostridium chauvoei.
The over-the-counter product, Combicillin-AG is indicated for
use in beef cattle for
bacterial infections due to the following microorganisms that are susceptible to the serum levels of
penicillin common to this particular dosage form: Bacterial pneumonia (shipping fever complex) caused by Streptococcus spp., Corynebacterium pyogenes, Staphylococcus aureus; Upper respiratory infections such as rhinitis or
pharyngitis caused by Corynebacterium pyogenes; Blackleg caused by Clostridium chauvoei. III. DOSAGE: A. DOSAGE FORM Combicillin and
Combicillin-AG are supplied in 100 mL or
250 mL vials containing 150,000 units per mL of
penicillin G benzathine and
penicillin G procaine, each in aqueous suspension. B. ROUTE OF ADMINISTRATION Dogs: Administered as a single subcutaneous or
intramuscular injection Horses: Administered as a single intramuscular injection Cattle: Administered as a single subcutaneous injection C. RECOMMENDED DOSAGES: Dogs: 1 mL per 10-25 lbs body weight or
6000 to 15,000 units of
penicillin G procaine and
penicillin G benzathine per lb of
body weight Horses: 2 mL per 150 lb body weight or
2000 units penicillin G procaine and
2000 units penicillin G benzathine per pound of
body weight.
This drug should not be used in horses intended for
food. Cattle: 2 mL per 150 lb body weight or
2000 units penicillin G procaine(beef) and
2000 units penicillin G benzathine per pound of
body weight. Treatment should be limited to two (2) doses. Treatment should be repeated in 48 hours. Cattle should be withheld from
slaughter for
food use for
30 days following the last treatment. NOTES IV. EFFECTIVENESS: The combination product, penicillin G benzathine and
penicillin G procaine was
the subject of
a final rule and
was
published in the
Federal Register of
February 16, 1979 (44 FR 10059).
The final rule amended the animal drug regulations (1) to indicate those portions which
reflect the National Academy of
Science-National Research Council, Drug Efficacy Study Group (NAS/NRC) evaluation of
the product and
(2) to specify the conditions of
use for
which approval of
similar products need not include certain types of
efficacy data, but may require submission of
bioequivalence or
similar data. Anthony's product has been shown to be bioequivalent to the pioneer product, Bristol's Flo-Cillin , (NADA 65-169) which
was
approved as effective (as well as safe) in 1979.
The name and
address of
the investigator is: Diane Fagerberg Colorado Animal Research Enterprises, Inc. 6200 East County Road 56 Fort Collins, Colorado 80524 Bioequivalency Study: The bioequivalence study
was designed as a 20-animal crossover trial in steers (beef cattle).
The 20 test animals were
randomized to two treatment groups after stratification for
body weight. Single, equivalent doses (600,000 IU/150 lbs body weight) of
either the Test or
the Reference product were
administered subcutaneously to individuals in 10-animal groups at each of
two periods that were
separated by a 28-day washout period. No adverse reactions were
observed during the study
. Blood samples were
collected from
each animal during each of
the two periods prior to drug administration and
14 times post-dosing: at 20 min; 40 min; 60 min; 80 min; 100 min; 120 min; 4 hr; 6 hr; 12 hr; 18 hr; 24 hr; 48 hr; 72 hr; and
96 hr. Serum was
analyzed for
penicillin G concentration by a cylinder-plate microbiological method using Micrococcus luteus (ATCC 9341a), with a limit of
detection less than or
equal to 0.025 IU/mL.
The method used is based on the method described in the
publication: "Antibiotic Residues-in Milk, Dairy Products, and

Animal Tissues: Methods, Reports and
Protocols.", National Center for
Antibiotic and
Insulin Analysis, Food and
Drug Administration, Dept. of
Health and
Human Services, Washington DC 20204. Bovine serum penicillin levels in response to both products during both periods of
the trial were
statistically analyzed. No statistically significant differences were
noted between the two drugs. Values for
serum levels over time, Ka, Tmax, Cmax, Ke, T1/2, Tp and
AUC were
very similar between the two products.
Therefore, it is concluded that Flocillin and
Anthony's products, Combicillin and
Combicillin-AG , are bioequivalent and
will be similarly effective when
used in cattle, horses, and

dogs. V. ANIMAL SAFETY: The pioneer product, Bristol Laboratories' Flo-Cillin NADA 65-169, was
approved as safe and
effective for
use as labeled on February 16, 1979 (44 Fed. Reg. 10059).
The demonstration of
bioequivalence to that product established that no additional target animal safety studies were
required for
Combicillin and
Combicillin-AG . VI. HUMAN SAFETY: The bioequivalence study
in cattle, described previously, demonstrates that the
two Anthony Products, Combicillin and
Combicillin-AG , are bioequivalent to the Bristol pioneer product. Residue depletion data gathered using equivalent, approved products have demonstrated that a preslaughter withdrawal period of
30 days in beef cattle is adequate to ensure that penicillin residues do not exceed 0.05 ppm in edible tissues of
treated animals. Combicillin and
Combicillin-AG will be assigned the same preslaughter withdrawal period on both labels.
This drug should not be used in horses intended for
food. Use of
this drug in beef cattle should be withheld for
30 days before slaughter for
human consumption. VII. AGENCY CONCLUSIONS: The data submitted in support of
this NADA satisfy the requirements of
section 512 of
the Act and
demonstrate that Anthony Products, Combicillin or
Combicillin-AG , when
used under
their labeled conditions of
use are safe and
effective in cattle, horses, and

dogs.
The sponsor submitted bioequivalency data which
demonstrated biological equivalence to the approved pioneer product.
This bioequivalency blood level study
was accepted in lieu of
tissue depletion.
Therefore, for
human food safety considerations, when
bioequivalence is demonstrated through blood level studies, the
DESI "Me-Too" product is assigned the same withdrawal period as the reference product (30 days).
The tolerance for
penicillin is established at 0.05 parts per million (negligible residue) in the
uncooked edible tissues of
cattle (See 21 CFR 556.510).
The pioneer injectable penicillin G benzathine and
penicillin G procaine product which
is currently on the market for
use in beef cattle only, is an over-the-counter drug. Adequate directions for
use have been written for
the layman, and

the conditions for
use are likely to be followed in practice.
Therefore, the
Center for
Veterinary Medicine has concluded that Combicillin-AG will also have over-the-counter marketing status. However, Combicillin which
is indicated for
use in horses, dogs, and

beef cattle, is limited to prescription status because it carries nonfood species indications (dogs and
horses) and
must be administered under
the supervision of
a licensed veterinarian. Under the Generic Animal Drug and
Patent Term Restoration Act of
1988, this approval does not qualify for
an exclusivity period under
section 512 (c)(2)(F)(ii) of
the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(ii)), this approval does not qualify for
marketing exclusivity because no new clinical or
field investigations other than bioequivalence or
residue studies and
no new human food safety studies other than bioequivalence or
residue studies were
essential to the approval and
conducted or
sponsored by the applicant. VIII. LABELING (Attached) 1. Combicillin-I00 mL 2. Combicillin-250 mL 3. Insert Combicillin-AG 100 mL 3. Insert Combicillin-AG 250 mL Copies of
applicable labels may be obtained by writing to the: Food and
Drug Administration Freedom of
Information Staff (HFI-35) 5600 Fishers Lane Rockville, MD 20857 Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414. FOI Summary; NADA 065-505 (supplemental); Combicillin / Combicillin-AG (penicillin G benzathine/ penicillin G procaine); re: satisfy the requirements of
section 512 of
the FD&C ACT (cattle, horses, and

dogs); --Editor's abstract Approval Date: Freedom of
Information Summary NADA Approval Date: Freedom of
Information Summary NADA I. GENERAL INFORMATION: NADA Sponsor: Generic Name: Trade Name: Marketing Status: : NADA Sponsor: Generic Name: Trade Name: Marketing Status: NADA NUMBER: Sponsor: Generic name: Trade names: Marketing status: 2. INDICATIONS FOR USE 3. DOSAGE FORM(S), ROUTE(S) OF ADMINISTRATION AND RECOMMENDED DOSAGE A. Dosage Form B. Route of
Administration C. Recommended Dosage 4. EFFECTIVENESS 5. TARGET ANIMAL SAFETY 6. HUMAN SAFETY 7. AGENCY CONCLUSIONS 8. APPROVED PRODUCT LABELING. Copies of
these labels may be obtained by writing to the: Food and
Drug Administration Freedom of
Information Staff (HFI-35) 5600 Fishers Lane Rockville, MD 20855 Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.

© 2011 Betterchem.com