Diphenhydramine HCl, at a 50 mg dose, and diphenhydramine citrate, at a 76 mg dose, are the only monograph-approved ingredients in FDA's final rule for OTC nighttime sleep aids. The final monograph, published in the Feb. 14 Federal Register, will take effect Feb. 14, 1990. Although the diphenhydramine ingredients had been Category III in the tentative final monograph, which was published in 1978, FDA determined that the ingredients were safe and effective prior to the final rulemaking and published a notice stating its findings in 1982. Diphenhydramine is the active ingredient in several currently marketed OTC sleep-aid products, including: Beecham's Sominex, Whitehall's Sleep-eze 3, Block Drug's Nytol, Miles' Nervine and Medtech's Compoz. Doxylamine succinate, an NDA-ed sleep-aid ingredient contained in Leeming's OTC Unisom, was not included in the final monograph. The final rule notes that NDA-ed doxylamine succinate products are not affected by the monograph. The rule adds that "if any manufacturer believes that there are adequate data establishing" safety and efficacy of the ingredient, the data "may be submitted in an appropriate citizen petition to amend the monograph." Several ingredients were considered in the sleep-aid rulemaking, but were not approved in the final monograph. The list of unapproved ingredients includes pyrilamine maleate, potassium bromide, sodium bromide and scopolamine hydrobromide. According to FDA, the ingredients are currently either not in use or in very limited use in sleep-aid products. In a future issue of the Federal Register, FDA plans to make a final decision on whether combining an OCT nighttime sleep-aid ingredient with an OTC analgesic is appropriate. Until that time, the combination of a monograph nighttime sleep-aid and an internal analgesic "are exempt from the requirements of the final rule," FDA said. The agency is currently reviewing two studies submitted by Bristol-Myers to support an analgesic/sleep-aid combination. Bristol-Myers markets the nighttime sleep-aid analgesic Excedrin PM (acetaminophen and diphenhydramine). The agency said that for a sleep-aid/analgesic combination to be acceptable, a target population would have to be identified and supporting studies would have to demonstrate that both ingredients relieve sleeplessness. "If a target population with concomitant pain and sleeplessness that clearly requires both an analgesic and a nighttime sleep-aid can be established," FDA explained, "labeling for such a combination would have to state clearly that it is for use only when both symptoms occur together, not when only one occurs and/or the other is anticipated." Based on diphenhydramine studies measuring sleep latency, the final monograph allows companies to say in product labeling that the sleep-aid either "'Helps you' or 'Reduces time to' fall asleep if you have difficulty falling asleep." Both claims had been Category III in the TFM. The monograph also approves the label claims: "For relief of occasional sleeplessness"; and "Helps to reduce difficulty falling asleep" for use in the boxed indications section of labeling. The sleep aid products must carry the warnings: "Do not give to children under 12 years of age"; ** "If sleeplessness persists continuously for more than two weeks, consult your doctor. Insomnia may be a symptom of a serious underlying medical illness"; ** "Do not take this product if you have asthma, glaucoma, emphysema, chronic pulmonary disease, shortness of breath, difficulty in breathing, or difficulty in urination due to enlargement of the prostate gland, unless directed by a doctor"; ** and "Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor."(ITEM 200)#050928M001J59307# #970804M001XFCWP5# (ITEM 201)(COPYRIGHT) 1989 F-D-C Reports, Inc., The Pink Sheet, February 20, 1989
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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