Summary of FDA Information:
Date of Approval: December 18, 2001
FREEDOM OF INFORMATION SUMMARY
ANADA 200-293
Indication for use: It is used for the treatment of edema associated with cardiac
insufficiency, acute noninflammatory tissue edema, physiological parturient edema of the
mammary gland and associated structures.
Sponsored by:
Phoenix Scientific, Inc.
St. Joseph, MO 64503.ANADA 200-293-E-0003 Page 2
FREEDOM OF INFORMATION SUMMARY
1. GENERAL INFORMATION:
ANADA Number 200-293
JINAD 10-179
Sponsor: Phoenix Scientific, Inc.
3915 S. 48 th St. Terrace
St. Joseph, MO 64503
21 CFR 510.600: Labeler Code 059130
Established Name: Furosemide Injection 5 %
Trade/Proprietary Name: Furosemide Injection 5 %
Dosage Form: Injectable
How Supplied: 50 & 100 mL multidose vials
How Dispensed: Rx
Amount of Active Ingredients: Each mL contains 50 mg of furosemide
as diethanolamine
Route of Administration: Intramuscularly or intravenously
Species: Cattle, horses, dogs and cats
Labeled Dosage Dog and cat-1/4 to ½ mL/10 lbs BID or SID
Horse-5 to 10 mL BID or SID
Cattle-5 mL BID or 10 mL SID
Indications for Use: Diuretic-saluretic for prompt relief of edema
Pharmacological
Category: Diuretic-saluretic.ANADA 200-293-E-0003 Page 3
Pioneer Product: Lasix ® 5% Injection manufactured by
Intervet, Inc. (NADA 034-478)
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. The ANADA
sponsor is required to show that the generic product is bioequivalent to the pioneer.
ANADA’s for drug products for food-producing animals will generally be required to
include bioequivalence and tissue residue studies. A tissue residue study will
generally be required to accompany clinical end-point and pharmacologic end-point
bioequivalence studies, and blood level bioequivalence studies that can not quantify
the concentration of the drug in blood throughout the established withdrawal period.
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, October, 2000).
Based upon the formulation characteristics of the generic product, Phoenix Scientific,
Inc. was granted a waiver on September 29, 1997, from conducting an in vivo
bioequivalence study for Furosemide Injection 5 %. The generic and pioneer
products contain the same active and inactive ingredients and are injectable solutions.
3. HUMAN FOOD SAFETY:
WITHDRAWAL TIME
When a waiver from the requirement of an in vivo bioequivalence study is granted,
the withdrawal times are those previously assigned to the pioneer product. The
withdrawal time for furosemide is established under 21 CFR 522.1010- 48 hours in
cattle. Milk taken during treatment and for 48 hours (four milkings) after the last
treatment must not be used for food.
Currently, there is no tolerance listed for the chemical component ‘furosemide’ in the
Code of Federal Register( section 21 CFR 556).
HUMAN SAFETY RELATIVE TO POSSESSION, HANDLING, AND
ADMINISTRATION:
Labeling contains adequate caution/warning statements..ANADA 200-293-E-0003 Page 4
4. AGENCY CONCLUSIONS:
This Abbreviated New Animal Drug Application (ANADA) filed under section
512(b) of the Federal, Food, Drug and Cosmetic (FFD&C) Act satisfies the
requirements of section 512(n) of the Act and demonstrates that Furosemide Injection
5 % is safe and effective for its labeled indications, when used under its proposed
conditions of use.
5. LABELING:
Attachments: Pioneer Labeling:
Package Insert
50 mL vial
Generic Labeling:
Package Insert
50 mL & 100 mL vials
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) 827-6567.