Novartis temporarily suspends production of Interceptor, Sentinel
Novartis Animal Health has ceased production of Interceptor, Sentinel and several other drugs manufactured in its plant in Lincoln, Neb., while the facility undergoes "process and compliance improvement activities," a spokesman for the company confirmed.
Mickey McDermott, head of communications for Novartis Animal Health in North America, could not immediately identify what other products are being impacted by the plant's temporary shutdown aside from Interceptor and Sentinel, both pet parasitides. He did not specify the type of modifications underway or whether they were prompted by the U.S. Food and Drug Administration (FDA), which regulates facilities that manufacture and process livestock feeds, pet foods and veterinary drugs and devices.
Officials with the FDA's Center for Veterinary Medicine did not respond today to a query about whether the agency is involved in Novartis's process and compliance upgrades.
McDermott noted that the changes are being made "voluntarily." The company hopes to resume its regular production schedule sometime in January.
"We're hoping this will be very temporary," he said.
So is Dr. Steven Hornstein. As a solo practitioner in Monroe Township, N.J., he dispenses 40 or 50 boxes of Interceptor, a broad-spectrum antiparasitic that contains milbemycin oxime, on a monthly basis.
Trifexis is not a direct substitute for Interceptor or Sentinel, which contains milbemycin oxime and lufenuron. According to the label for Trifexis, serious adverse reactions have been reported following concomitant extra-label use of ivermectin, another broad-spectrum antiparasiticide, with spinosad alone, one of the components of Trifexis chewable tablets.
The most recent news releases featured on the Novartis U.S. website date back to 2009. It's unclear whether Novartis sent a "Dear Doctor" letter — a form of communication that pharmaceutical companies often use to alert medical professionals to changes concerning their products — to veterinarians.
"Would it be nice for the company to warn us? Absolutely," Hornstein said. "I'd like to get this information first, from them."
This article was provided by the Veterinary Information Network.