CFR

250.102—Drug preparations intended for human use containing certain “coronary vasodilators”.

(a) (1) The Food and Drug Administration finds that the following “coronary vasodilators” are extensively regarded by physicians as safe and useful as employed under medical supervision for the management of angina pectoris in some patients:

Amyl nitrite.

Erythrityl tetranitrate.

Mannitol hexanitrate.

Nitroglycerin.

Potassium nitrite.

Sodium nitrite.

(2) Additionally, new-drug applications have been approved for products containing:

Inositol hexanitrate.

Isosorbide dinitrate.

Octyl nitrite.

Pentaerythritol tetranitrate.

Triethanolamine trinitrate biphosphate (trolnitrate phosphate).

(b) The Food and Drug Administration also finds that there is neither substantial evidence of effectiveness nor a general recognition by qualified experts that such drugs are effective for any of the other purposes for which some such drugs are promoted to the medical profession in labeling and advertising. In particular, neither clinical investigations nor clinical experience justify any representations that such drugs are effective in the management of hypertension; in the management of coronary insufficiency or coronary artery disease, except for their anginal manifestations; or in the management of the post coronary state, except angina pectoris present after coronary occlusion and myocardial infarction.

(c) Any preparation containing such drugs that is labeled or advertised for any use other than management of angina pectoris, or that is represented to be efficacious for any other purpose by reason of its containing such drug, will be regarded by the Food and Drug Administration as misbranded and subject to regulatory proceedings, unless such recommendations are covered by the approval of a new-drug application based on a showing of safety and effectiveness.

(d) Any such drug in long-acting dosage form is regarded as a new drug that requires an approved new-drug application before marketing.

(e) Any of the drugs listed in paragraph (a)(2) of this section is regarded as a new drug that requires an approved new-drug application. Articles for which new-drug approvals are now in effect should be covered by supplemental new-drug applications as necessary to provide for labeling revisions consistent with this policy statement.

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