SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.
The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said. The drug maker announced its receipt of a complete response letter from the agency for its application for rabeprazole sodium extended-release capsules, a proton-pump inhibitor for GERD. The FDA delivers a complete response letter when it has finished reviewing a regulatory approval application, but issues remain that preclude final approval of the drug.
The Food and Drug Administration has approved a generic weight-loss drug made by Elite Pharmaceuticals. Elite announced the approval of phentermine hydrochloride in the 37.5-mg strength, a generic version of Teva’s Adipex-P. Branded and generic versions of the drug had sales of around $40 million in 2010, according to Elite.
The Food and Drug Administration approved Sun Pharmaceutical Industries’ generic version of Johnson & Johnson’s Alzheimer’s drug, Razadyne (galantamine hydrobromide) tablets. Razadyne has annual sales of about $50 million, according to Sun.