REQUA ANTIFLATULENT STUDIES: ACTIVATED CHARCOAL SUPERIOR TO SIMETHICONE, currently the only product with Category I status under FDA's Final Monograph for OTC antiflatulent products. In a study of breath hydrogen levels, 10 patients were randomly tested with a noncarbohydrate placebo, activated charcoal (260 mg per capsule), and simethicone (20 mg per capsule). Compared to placebo, "activated charcoal reduced peak breath H[2] levels," Requa reported, while simethicone "did not result in significant reduction in breath H[2] levels." Moreover, "data clearly indicate that activated charcoal is an effective anti-gas medication," Requa stated. "Simethicone, also commonly prescribed for gaseousness, was not found to be effective." The simethicone comparison study is one of three randomized, double-blind, placebo-controlled studies submitted by Requa to FDA on Oct. 27. Requa is seeking Category I(END ITALICS) status for Charco-caps activated charcoal capsules. According to Requa, the recently submitted studies "have shown activated charcoal to be effective, to a statistically significant degree, in reducing breath hydrogen, and by extrapolation, intestinal gas." For approved labeling, Requa proposed: "To alleviate or relieve the symptoms of gas. . . . Take 2-4 capsules 30 minutes before and after meals or at the first signs of discomfort or as directed by your physician. Repeat 1/2 to one hour as needed up to 10 gm/per day, not to exceed 7 days." The company noted that FDA might revoke the Antiflatulent Final Monograph and reclassify all antiflatulents as digestive aids under a proposed Digestive Aid Drug Products Monograph. In that case, Requa asked that FDA "reopen the administrative record for the Proposed Digestive Aid Drug Products Monograph to recategorize activated charcoal as a Caegory I digestive aid ingredient for the treatment of intestinal distress." Last summer, Requa submitted a 51-patient study in support of an OTC antidiarrhea claim. In that study 58% of patients receiving the activated charcoal product experienced "very good" relief of symptoms, compared to 38% of placebo patients, Requa reported. The company also submitted a petition requesting FDA to reopen the administrative record for the Antidiarrheal Tentative Final Monograph to reclassify activated charcoal from Category III to Category I prior to publication of the final monograph ("The Pink Sheet" July 6, T&G-3).
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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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