ROBINS' DIMETANE, B-W's ACTIFED-C, DROPPING EXPECTORANT INDICATION as part of a Drug Efficacy Study Implementation (DESI) reformulation, FDA noted in a Jan. 3 Federal Register notice. NDA supplements filed with FDA by Robins propose "to provide for a reformulation that changes the name from Dimetane Expectorant to Dimetane-DM Cough Syrup" and a second reformulation "that changes the name from Dimetane Expectorant-DC to Dimetane-DC Cough Syrup," the notice stated. A similar reformulation of Burroughs Wellcome's (B-W) Actifed-C Expectorant would be accompanied by a change in name to Actifed-C Cough Syrup, according to the notice. All three reformulations eliminate the ingredient guaifenesin. Also, the Dimetane cough syrups will no longer contain phenylephrine. In another DESI notice last week, FDA said that Robins was also removing phenylephrine from its Dimetapp decongestant/antihistamine product line. Although FDA said that Robins and BW are reformulating under new names, the agency noted that "hearing requests are still pending on the product formulations identified as Dimetane Expectorant, Dimetane Expectorant-DC, and Actifed-C Expectorant." B-W said it is still considering whether to pursue the DESI hearing for the four-ingredient expectorant formulation. Last year, FDA evaluated the results of a clinical study conducted by Robins to support the efficacy of guaifenesin as an OTC product expectorant and concluded that the data justified a reclassification of the ingredient from Category III to Category I. Although that data was submitted to FDA's OTC Div. to maintain guaifenesin as an ingredient in Robin's Robitussin line of OTC cough/cold products, the information could also be used by the company in a hearing on the DESI status of the Dimetane products. FDA is willing to approve the reformulated versions, however, the notice states. "FDA has reviewed all available evidence and concludes that the drug products, as reformulated, are effective for . . . the relief of coughs and upper respiratory symptoms, including nasal congestions, associated with allergy or the common cold."
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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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