BioCentury
ARTICLE | Tools & Techniques

Zonagen: No one asked the rats

August 16, 1999 7:00 AM UTC

FDA could be sending a message that decades of use won't lower the regulatory risk for new applications of a compound, especially when the agent's development history doesn't include now-common tests.

Thus, safety studies in rats performed by Zonagen Inc. to support its use of phentolamine mesylate to treat sexual dysfunction have raised concerns at the agency over a compound that has been marketed since the 1950s...