Zdrowie i gospodarka · 16/04/2004

FDA Revokes Temporary Exemption for Isocarboxazid, Announces Marketing Conditions

The FDA is revoking the temporary exemption that allowed isocarboxazid products to stay on the market beyond their scheduled implementation deadline for the Drug Efficacy Study. The agency has announced the conditions under which isocarboxazid can be marketed for its approved indication, a treatment for depression, and is providing an opportunity for public hearing on the matter.