PFPC Daily - December 28, 2004

NOTE: Deramaxx (deracoxib)is:
4-[3-(difluoromethyl)5-(3-fluoro-4-methoxyphenyl)1H-pyrazol-1-yl

"FDA Novartis Late with Dog Painkiller Reports"

Reuters - Dec. 28, 2004

WASHINGTON (Reuters) - Novartis AG failed to give the government
prompt, accurate reports about deaths of dogs treated with a
painkiller in the same class of medicines now linked to heart
problems in humans, U.S. regulators have charged in a letter.

The drug, Deramaxx, is a COX-2 inhibitor approved for relieving
arthritis and post-surgical pain in dogs.

Similar drugs for people are under heavy scrutiny after studies
associated them with heart attacks and strokes. One of the drugs,
Merck & Co Inc.'s Vioxx, was pulled from the market because of safety
risks.

Death has been reported "in rare situations" when dogs were treated
with Deramaxx, according to the drug's label instructions.

The Food and Drug Administration, in a warning letter dated Nov. 29,
said Novartis Animal Health Services should have forwarded complaints
about deaths and health problems in dogs given Deramaxx within 15
working days, but in some cases delayed as long as 10 months. Some
reports, including ones involving deaths, appeared to have incorrect
dates, the FDA said.

"Novartis failed to submit timely and accurate information to the FDA
regarding serious (adverse drug experiences) associated with the
administration of its FDA-approved animal drug product Deramaxx ...
during its first year of marketing," the FDA said.

The company also failed to submit proper information about
post-approval studies of Deramaxx, the FDA charged. The drug is known
generically as deracoxib.

Novartis officials could not immediately be reached for comment.

The FDA sends dozens of warning letters per year. Most of the issues
raised are resolved without further regulatory action, although the
letters sometimes lead to tougher steps such as product seizures.

The warning letter to Novartis is posted on the FDA Web site at
http:/www.fda.gov/foi/warning_letters/g5108d.pdf

SOURCE:
http://tinyurl.com/5un52