Approval Date: November 7, 1997
I. GENERAL INFORMATION:
I.D. Russell Company Laboratories
1301 Iowa Avenue
Longmont, CO 80501
Dosage Form: Soluble Powder
How Supplied: 40 g packets
How Dispensed: OTC
Amount of Active Ingredients: Each packet contains lincomycin hydrochloride equivalent to 16 g of lincomycin
Route of Administration: Orally in drinking water
Species: Swine and chickens
Labeled Dosage and Administration:
- Dosage: At a dose rate of 250 mg of lincomycin per gallon of drinking water. In clinical studies, this dose rate provided an average of 3.8 mg of lincomycin per pound of body weight per day.
- Treatment period: The drug should be administered for a minimum of 5 consecutive days beyond the disappearance of symptoms (bloody stools) up to a maximum of 10 consecutive days.
- Administration: One packet (40 g) will medicate 64 gallons of drinking water providing 250 mg/gallon.
- Broiler Chickens:
- Dosage: At a dose rate of 64 mg of lincomycin per gallon of drinking water.
- Treatment Period: The drug should be administered for 7 consecutive days.
- Administration: One packet (40 g) will medicate 250 gallons of drinking water providing 64 mg/gallon.
Indications for Use: Lincomycin Soluble is used in swine for the treatment of dysentery (bloody scours) and in broiler chickens for the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin.
Pioneer Product: Lincomix Soluble Powder, The Upjohn Company, NADA 111-636.
II. 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 and the Center's first policy letter (53 FR 50460, December 15, 1988), an Abbreviated New Animal Drug Application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). For certain dosage forms, the Agency may grant a waiver from conducting an in vivo bioequivalence study (55FR 24645, June 18, 1990; fifth GADPTRA Policy Letter). In lieu of bioequivalence testing, the safety and efficacy of the generic product are based on the demonstrated chemical equivalence to the pioneer product.
Based on the formulation characteristics of the generic product, I.D. Russell Company, Laboratories was granted a waiver from conducting an in vivo bioequivalence study with Lincomycin Soluble. The generic and pioneer products contain the same active ingredient and are water soluble powders administered as oral solutions. The generic product contains no inactive ingredients that may significantly affect the bioequivalence of the active ingredient.
III. HUMAN SAFETY
Human Safety Relative to Food Consumption
- Tolerance: The tolerances established for the pioneer product apply to the generic product. A tolerance of 0.1 part per million is established for negligible residues in the edible tissues in swine under 21 CFR 556.360(a). A tolerance for residues of lincomycin in chickens is not required under 21 CFR 556.360(b).
- 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 times for lincomycin HCl soluble powder are established under 21 CFR 520.1263c: Six days for swine and zero days for broiler chickens. Lincomycin HCl soluble powder is not approved for use in layer and breeder chickens.
- Regulatory Method for Residues: The regulatory analytical method for detection of residues of the drug is a microbiological test using Sarcina lutea (ATCC 9341). The method is on display in FDA's Freedom of Information Public Room, 5600 Fishers Lane, Rockville, MD 20857.
Human Safety Relative to Possession, Handling and Administration
Labeling contains adequate caution/warning statements.
IV. AGENCY CONCLUSIONS
This ANADA submitted under section 512(b) of the Federal Food, Drug, and Cosmetic Act satisfies the requirements of section 512(n) of the act and demonstrates that Lincomycin Hydrochloride Soluble Powder when used under the proposed conditions of use, is safe and effective for its labeled indications.
- generic product labeling
- pioneer product labeling
Copies of applicable labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855