Mylan garners FDA approval for generic versions of Duragesic, Valtrex

Mylan received FDA approval to market a generic version of Johnson & Johnson's fentanyl patch, Duragesic. Also on Wednesday, US regulators granted tentative approval to Mylan's generic version of herpes treatment, Valtrex (valacyclovir), which is marketed by GlaxoSmithKline.

Regarding the fentanyl pain patch, Mylan noted that it received approval to market a 12-microgram-per-hour dosage of the drug, which it plans to start shipping immediately. The company indicated in a statement that it is the first to sell generic transdermal fentanyl in five strengths. Meanwhile, the tentative approval for generic Valtrex tablets covers two dosages, for which Glaxo recorded $1.26 billion in branded US sales in the 12 months ended September 30, according to data from IMS Health.

Separately, Mylan revealed that Dr. John O'Donnell, the company's chief scientific officer, will retire from his post as of April 1, but will stay on at the company as a strategic scientific advisor. Additionally, the drugmaker named Rajiv Malik to the position of head of global technical operations, and promoted Heather Bresch to head of North American operations. Mylan commented that the re-organisation follows its acquisition of a controlling interest in Matrix Laboratories.

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