NDAed OTC product exemption from FDA OTC labeling rule sought by J&J/Merck.

NDAed OTCs SHOULD BE EXEMPT FROM FDA LABELING RULE, J&J/MERCK say, because of "unique and complex labeling messages which may not be formatted to the exact intent of CFR [the Code of Federal Regulations]," the consumer products joint venture stated in Sept. 30 comments to FDA on its Feb. 27 proposed revisions to OTC drug labeling. The company believes FDA "intends to recognize and waive those cases where the approved labeling need not necessarily be in complete conformance with the final rule as long as the specific label has undergone FDA review and approval," J&J/Merck writes, asking FDA to clarify the status of NDAed over-the-counter drugs in the final rule.