FDA Sued For Questioning Lupus Product's Label

Law360, Chicago (June 13, 2013, 3:42 PM EDT) -- Health Science Funding LLC sued the U.S. Food and Drug Administration in New Jersey federal court Thursday, seeking a declaration that the label for its Prastera treatment for women with lupus complies with federal law and an order barring the agency from taking enforcement action saying otherwise.

The company that markets the oral soft gels alleges that after it asked the FDA to review Prastera's label in September to confirm that it complies with federal law governing "medical food," the agency said it had "serious questions...
To view the full article, register now.