Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel
other · Food and Drug Administration · Rule · Published 2010-09-03 · Effective 2010-09-03 · 75 FR 54018
Document
Document number
2010-22043
Federal Register citation
75 FR 54018
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2010-09-03
Effective date
2010-09-03
HHS docket
Docket No. FDA-2010-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Bayer HealthCare LLC. The supplement provides for two new sizes of praziquantel and pyrantel pamoate tablets used in cats and kittens for the removal of various internal parasites and for a revised kitten age and weight restriction.