Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Containing an Anticholinergic or Antispasmodic in Combination With a Sedative, and Single-Entity Antispasmodic Drug Products, in Oral Dosage Form; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing that all outstanding hearing requests regarding drug products containing an anticholinergic or antispasmodic in combination with a sedative, and single-entity antispasmodic drug products, in oral dosage form, under Docket FDA-1975-N-0336 (formerly 75N-0184) (DESI 10837) have been withdrawn. Therefore, shipment in interstate commerce of any such product identified in Docket FDA-1975-N-0336 covered by DESI 10837, or any identical, related, or similar (IRS) product, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) is unlawful as of the date of this notice. This notice does not affect products covered by DESI 597 under the same docket.
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