Mucinex supplemental NDA approved
This article was originally published in The Tan Sheet
More than a year after Reckitt Benckiser acquired Adams Respiratory Therapeutics, the firm receives FDA's approval to change the debossing of the modified release layer from "A" to "RB" on its MucinexExtended-Release Bi-Layer tablets, according to an April 3 approval letter for a supplemental new drug application (1"The Tan Sheet" Feb. 4, 2008, In Brief). The FDA also approved changing the tablet shape from round to modified oval and allows for blister packaging. Another April 3 FDA approval letter allows Reckitt to change the debossing of the MR layer of Mucinex DM Extended-Release Bi-Layer tablets from "Adams" to "RB.
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U.K.-based Reckitt Benckiser completes the acquisition of Adams Respiratory Therapeutics, makers of Mucinex-brand cough/cold products, through a cash tender offer "followed by a short-form merger of its indirect wholly owned subsidiary, Twickenham, with and into Adams," the firm announces Jan. 30. Reckitt announced plans to pay remaining Adams shareholders $60 per share, the same price paid in the tender offer made in December 2007, the firm says (1"The Tan Sheet" Jan. 28, 2008, In Brief)...
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