Zdrowie i gospodarka · 23/06/1998

FDA Revokes Exemption for Erythrityl Tetranitrate Drug Products

The FDA is revoking the temporary exemption for single-entity coronary vasodilator drug products containing erythrityl tetranitrate, citing a lack of substantial evidence of effectiveness, and is offering a hearing on a proposal to withdraw approval of applicable NDA's and ANDA's.