PARKE-DAVIS EXPANDING OTC DIPHENHYDRAMINE HCI FRANCHISE WITH BENADRYL antihistamine products, the firm announced in a May 21 release. Parke-Davis (P-D), which currently markets diphenhydramine OTC in the antitussive Benylin, said it will introduce its three OTC Benadryl formulations by the end of May. The three formulations are Benadryl 25 (25 mg caps), Benadryl Elixir for children, and Benadryl Decongestant capsules, which contain 25 mg diphenhydramine HCl and 60 mg pseudoephedrine, the firm said. The elixir contains 12.5% diphenhydramine. With the introduction of the new Benadryl products, P-D will apparently be the first firm to take advantage of the OTC availability of diphenhydramine HCl as an antihistamine. In the Antihistamine Tentative Final Monograph, published in January, FDA said it would allow OTC indications for the ingredient. In permitting the ingredient for OTC antihistamine use the agency said that products must carry a label statement: "May cause marked drowsiness" ("The Pink Sheet" Jan. 21, p. 13). P-D's effort to break into the OTC antihistamine market with Benadryl comes two weeks after approval of Merrell Dow's non-sedating Rx antihistamine Seldane. In letters to MDs announcing the OTC products, P-D VP Marketing C. J. Cowles asserted the company will maintain a strong commitment to the Rx product. The company "will continue its strong ethical promotion of Benadryl on Rx to physicians through Journal advertising, detailing, sampling, direct mail, and at conventions," Cowles said. "At the same time physician recommendations for Benadryl OTC will be encouraged." He pointed out to the MDs that "for all indications other than hay fever, other upper respiratory allergies and the common cold, Benadryl remains available only on your Rx." The whsle. prices for the Benadryl products are: $2.07 for a box of 24 of the 25 mg capsules; $2.58 for a box of 24 of the decongestant capsules; and $2.27 for a 4 oz. bottle of the elixir, the firm said. The OTC launch will be supported by print ads and natl. television commericals.
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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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