Lincomycin Hydrochloride Monohydrate: what the FDA reviewed for dog products

Lincocin® Lincomix® 25 Injectable Lincomix® 50 Injectable Lincomix® 100 Injectable Lincomix® 300 Injectable NADA 034-025, Supplemental approval, August 25, 1998; sponsor Zoetis Inc.; species: Dogs and Cats; Swine (no Species/Class field; indications listed for Dogs and Cats and for Swine; this supplement concerns swine only); foi_id 296; FDA PDF

Indication

Dogs and cats: infections caused by Gram-positive organisms, particularly streptococci and staphylococci. Swine: treatment of infectious arthritis and mycoplasma pneumonia.

Dose regimen

Injectable (LINCOCIN Sterile Solution / LINCOMIX Injectable); dosage not restated in this supplement, Referenced to the FOI Summary for the original approval of NADA 34-025 (June 6, 1967)

As discussed in the Freedom of Information (FOI) Summary for the original approval of NADA 34-025 dated June 6, 1967.

Extraction notes: Category II supplement (1998) establishing swine tolerances (0.6 ppm lincomycin in swine liver, 0.1 ppm retained in muscle) and an ADI of 25 micrograms/kg/day; contains only human food safety content (swine residue depletion studies 768-9760-89-001 and 768-7926-95-004 at 5 mg/lb (11 mg/kg) IM once daily for 3 days; 2-day swine withdrawal). No dog data, no target animal safety or effectiveness re-evaluation ('did not require a reevaluation of target animal safety or effectiveness data in the parent application').