POOLE, Circuit Judge:
We affirm the decision of the Commissioner of the Food and Drug Administration withdrawing approval of petitioner's new drug application.
FACTS
Brandenfels Scalp and Hair Applications and Massage is an aqueous solution of 0.25% sulfanilimide and an aqueous solution of 1.5% lanolin. The labeling reviewed by the Food and Drug Administration's (FDA) scientific panels claimed that the treatment tends to soften the scalp, to remove...
Let's get started
Welcome to the leading source of independent legal reporting
Sign on now to see your case.
Or view more than 10 million decisions and orders.
- Updated daily.
- Uncompromising quality.
- Complete, Accurate, Current.