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February 2, 1976

The Drug Lag

Author Affiliations

Ayerst Laboratories, New York

JAMA. 1976;235(5):475. doi:10.1001/jama.1976.03260310011003

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To the Editor.—  In referring to propranolol and its indication for hypertension, Dr Crout states that the delay in consideration of the pending New Drug Application (NDA) resulted from the sponsor's not submitting the NDA until December 1974. That submission date is correct; however, if one examines the Food and Drug Administration's (FDA's) action record on propranolol in its entirety, Dr Freis' contention of a drug lag is not refuted.The original submission of an NDA for use of propranolol in arrhythmias occurred on June 3, 1966, and approval was received on Nov 13, 1967— not a serious delay for a new drug. However, the NDA for use of propranolol in angina, originally submitted on April 4, 1968, was not approved until Sept 4, 1973—a period of more than five years. From 1969 to 1972, the attitude within the reviewing division was unreceptive, if not hostile, to propranolol, to β-adrenergic