Approval Date: April 8, 1998
I. GENERAL INFORMATION
Phoenix Scientific Inc.
3915 South 48th Street Terrace
P.O. Box 6457
St. Joseph, MO 64506-0457
II. INDICATIONS FOR USE
For intravenous use as a skeletal muscle relaxant for horses.
A. DOSAGE FORM: Injectable solution
B. ROUTE OF ADMINISTRATION: IntravenousOne (1) mL per pound of body weight
C. RECOMMENDED DOSAGES: One (1) mL per pound of body weight
IV. & V. EFFECTIVENESS AND ANIMAL TARGET
Under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act of 1988, an abbreviated new animal drug application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product) [53 FR 50460, December 15, 1988, First GADPTRA Policy Letter]. 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, 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 (Fifth GADPTRA Policy Letter: 55 FR 24645, June 18, 1990; Bioequivalence Guidance: 61 FR 26182 - 26186, May 24, 1996).
Based upon the formulation characteristics of the generic product, Phoenix Scientific, Inc. was granted a waiver from conducting an in vivo bioequivalence study for Guaifenesin Injection. The generic and pioneer products contain the same active ingredients in the same concentration and are injections for intravenous administration.
VI. HUMAN SAFETY
Human Safety Relative to Food Consumption
None required as the product is intended for use in horses only. The labeling contains the statement "Warning: Not to be used in horses intended for food."
Human Safety Relative to Possession, Handling and Administration
Labeling contains adequate caution/warning statements.
VII. AGENCY CONCLUSIONS
This is an Abbreviated New Animal Drug Application (ANADA) filed under section 512(b)(2) of the Federal, Food, Drug and Cosmetic (FFD&C) Act. Bioequivalence of this generic animal drug, Guaifenesin Injection, was established by demonstration of chemical equivalence to the pioneer product, Summit Hill Laboratories' Gecolate® (NADA 048-854). This generic product and the pioneer product have identical labeling indications for use in horses. The route and method of administration of the two drugs are identical. Both drugs are administered by intravenous injection. The generic and pioneer products contain the same active ingredients and are the same strength. Therefore, in compliance with FDA policy implementing section 512(b)(2) of FFD&C Act in vivo bioequivalency studies were not necessary nor required.
This ANADA satisfies the requirements of section 512 of the Act and demonstrates that Guaifenesin Injection, is safe and effective for its labeled indications when used under it proposed conditions of use.
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.