Approval Date: November 17, 1986
Freedom of Information Summary
NADA 138-405
I. GENERAL INFORMATION:
NADA 138-405 Sponsor: Anthony Products Company
5600 Peck Road
Arcadia, CA 91006Generic Name: pyrilamine maleate injection Trade Name: Pyrilamine Maleate Injection Marketing Status: Prescription II. INDICATIONS FOR USE
For use in horses for treatment of conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease, such as laminitis.
III. DOSAGE
A. DOSAGE FORM Injection B. ROUTE OF ADMINISTRATION Intravenous C. RECOMMENDED DOSAGES:
HORSES:
2 to 3 ml per 100 lbs of body weight; FOALS: 1 ml per 100 lbs of body weight. Dose may be repeated in 6 to 12 hours if necessary. VI. SAFETY AND EFFICACY
Pyrilamine Maleate Injection (Histosol, NADA 7-404) was the subject of a review by the National Academy of Sciences/National Research Council (NAS/NRC), Drug Efficacy Study Group, the results of which were published in the FEDERAL REGISTER of July 22, 1970 (35 FR 11713). NAS/NRC concluded, and FDA concurred that the product was "probably effective" for use in cattle, horses and dogs in conditions where antihistaminic therapy may be expected to lead to alleviation of some signs of disease. The product was raised to "effective" after deletion of claims in cattle and dogs as there was inadequate safety data for these species. FDA concluded that the use of pyrilamine maleate injection must be limited to horses (not for food use). A regulation was published as Section 522.2063. The FEDERAL REGISTER publication date December 2, 1977 on Pyrilamine Maleate Injection states that applications providing for the effective conditions of use identified in the regulation need not include data required establish the effectiveness of the drug for these uses.
Under Center for Veterinary Medicine policy, the principles of CFR 320.22 providing for a waiver of the requirement for submission of evidence of in vivo bioavailability and bioequivalence are applied to NAS/NRC-reviewed true solutions administered IV that were found to be effective. Therefore such data were neither required nor submitted.
V. ANIMAL SAFETY
Data on human safety, pertaining to consumption of drug residues in food, were not required for approval of this NADA. The drug is approved for use only in horses that are not to be used for food and is to be labeled: Not to be used in horses intended for food.
VI. HUMAN SAFETY:
Human safety relative to possession, handling and administration:
No specific caution statement required.
VII. AGENCY CONCLUSIONS:
The data submitted in support of this New Animal Drug Application comply with the requirements of Section 512 of the Act and 514.111 of the implementing regulations. It demonstrates that Pyrilamine Maleate Injection, when used under its labeled conditions of use, is safe and effective.
For the safe and effective intravenous use of Pyrilamine Maleate Injection in horses, it is necessary to provide a differential diagnosis of the disease causing pathology which only a trained professional can accomplish. Thus, the expertise of a veterinarian is necessary for safe and effective administration. Accordingly, labeling must bear the veterinary prescription legend.
VIII. LABELING (Attached)
1. Pyrilanime Maleate Injection package label
Copies of this label 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.