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Executive Summary

IBUPROFEN 200 MG IS "STRONG CANDIDATE" FOR MONOGRAPH inclusion, FDA OTC Drug Evaluation Division Director William Gilbertson, PharmD, told a May 8 Drug Information Association meeting on Rx-to-OTC switches. Noting that the internal analgesic monograph is open for submissions until November of this year, Gilbertson pointed out that ibuprofen 200 mg "has been used for several years now, [and] it's been widely used." Therefore, he said, the product "might be a strong candidate" to be included in the monograph. Currently, sponsors wishing to manufacture OTC ibuprofen (200 mg) must submit ANDAs to FDA. Inclusion in the monograph would allow manufacturers to go to market without submitting bioequivalence information and other data necessary for ANDA approval. Monograph status would also provide advantages for companies that already market OTC ibuprofen: the monograph procedure provides for more flexible labeling and does not require a sponsor to obtain preapproval for manufacturing changes. Periodic reports required under the NDA/ANDA process are also not necessary for monographed products. Gilbertson hinted that FDA is considering moving a few OTC products back to prescription status. "We have gone from OTC to Rx" before, Gilbertson said. A number of years ago "hexachlorophene, which is an antimicrobial, was switched back to Rx status, and there are a few more in the wind." FDA currently has two switch petitions under review. The Health Research Group petitioned the agency on Dec. 1 to ban OTC sales of quinine sulfate ("The Pink Sheet" Dec. 5, T&G-13). Two weeks later, HRG petitioned FDA to restrict promethazine to prescription-only status ("The Pink Sheet" Dec. 19, T&G-15). FDA proposed OTC status for promethazine in the tentative final monograph for cough/cold products, published Aug. 12, 1988. One day prior to publication of the monograph, the agency approved Wyeth's supplemental NDAs to market its promethazine products, Phenergan DM and Phenergan VC, as OTCs. Gilbertson also noted that the agency has established an internal OTC task force that will discuss switch products. The task force includes staff from the OTC division and new drug review offices. In addition to Gilbertson, the task force includes Office of Drug Evaluation I Director Robert Temple, MD, and Deputy Director Paula Botstein, Office of Drug Standards Director Peter Rheinstein, MD, "as well as others," Gilbertson reported. A reprise of an internal OTC task force that met in the early 1980s, the group, Gilbertson said, is "going to try to keep close together, communication-wise, on future switches, because people do shop around -- they come to our office, they go to other offices . . . and I think it's important . . . that we are all aware of what's going on with the switch." Gilbertson reported that "one of the things we're thinking about is . . . [developing] some type of a list of the type of things we are looking for [to support a switch] that would be made available early on so you could consider these standards or parameters before coming to the agency."

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