Back to Top

The FDA changed all species approvals from OTC to Rx for the following drugs. All shall bear the following warning: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

June FDA changes in Marketing Status:
200-123 Maxim-200® Injection, Oxytetracycline Hydrochloride Injection 200mg
200-128 Agrimycin® - 200
200-147 Genta-Ject®, Gentamicin Sulfate Injection
200-154 Oxytetracycline 200, Pennox™ 200
200-174 Gentamicin Sulfate Pig Pump Oral Solution
200-364 Spectogard Scour-Chek™
200-394 Gentamicin Piglet Injection
200-452 Oxytet 100
200-468 GentaMed™-P for Poultry Injection
200-537 Tetroxy®-LA (formerly OxyMed™ LA)

August FDA changes in Marketing Status:
110-315 Component® E-C with Tylan®, Component® E-S with Tylan®
118-123 Encore®
135-906 Component® E-H with Tylan®
200-221 Gentamicin Piglet Injection
200-224 Spectogard Scour-Chek™
200-346 GentaMed™-P for Poultry Injection

The manufacturers' requested the FDA change the marketing status from "Approved" to "Withdrawn" because the following products are no longer manufactured or marketed.
Drugs voluntarily withdrawn:

140-954 SAFE-GUARD® plus LINCOMIX®
141-002 OXY 1000 Calf Bolus, OXY 500 Calf Bolus
200-191 Gentasol

Corrections:
200-117
Oxyshot® LA; Tetroxy® - LA
changed the class from Dairy, all uses classes to non-lactating Dairy
200-117
Oxyshot® LA; Tetroxy® - LA
changed the class from Beef, all use classes to Beef, excluding veal calves