Tuesday, the generics behemoth won FDA approval for its knockoff for all Concerta strengths. And unlike the two versions the FDA just booted, from Mallinckrodt and Lannett’s Kremers Urban, “it seems like Mylan did get an AB rating,” Evercore ISI analyst Umer Raffat wrote in a note to clients--meaning it’s substitutable for the original.
Two drug makers — Mallinckrodt and Lannett — are fighting the US Food and Drug Administration over a plan the agency announced last week to withdraw their generic versions of the Concerta pill for attention deficit disorder. Mallinckrodt is trying to contest the move in court, while Lannett plans to seek a hearing in hopes of convincing the agency to change its mind.
Kremers Urban Pharms Generic Buprenorphine Hydrochloride; Naloxone Hydrochloride Approved In US
Kremers Urban Pharm`s Generic Potassium Chloride approved in US for Hypokalemia
Kremers Urban Pharms Generic Temozolomide approved in US an anti-cancer chemotherapy drug
Lannett Company, Inc. (NYSE: LCI) today announced a number of restructuring actions (the Plan) to streamline operations, improve efficiencies and significantly reduce costs. The initiatives are part of the company's efforts to integrate the recently completed acquisition of Kremers Urban Pharmaceuticals Inc. (KU). Actions have already begun and include the closing of KU's corporate offices in Princeton, New Jersey, an immediate workforce reduction of approximately 10% and a total staff reduction of approximately 20% over the next three years.
Lannett Company, Inc. (NYSE: LCI) today announced that, following a review of its operations including the recently acquired Kremers Urban Pharmaceuticals Inc. (KU), it expects to achieve approximately $40 million of cost reductions during the first 12 months following the close of the acquisition, with additional savings in later years.
Lannett Company has completed the acquisition of Kremers Urban Pharmaceuticals Inc. (KU), the US specialty generic pharmaceuticals subsidiary of global biopharmaceuticals company UCB.
After yesterday’s report that Thousand Oaks, Calif.-based Amgen (AMGN) might be considering a big acquisition, today analysts are speculating on possible targets. nAn unnamed source, presumably a company insider or top investor with inside information, told The Financial Times that Amgen was considering acquisition targets in the $10 billion range. Amgen has mostly avoided large acquisitions since its Onyx Pharmaceuticals, Inc. purchase in 2013 for about $10 billion. In that deal, Amgen also acquired the rights to Kyprolis, a cancer drug, but the drug’s initial sales were slow, causing dissent among investors.