FDAnews Drug Daily Bulletin
Oct. 19, 2012 | Vol. 9 No. 206
Despite liver toxicity concerns, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13–2 to recommend approval of Aegerion Pharmaceuticals’ lomitapide.
Mexico’s drug regulator Cofepris has doubled its clinical trial protocol review timeline, with approvals coming in six months now instead of three, an expert says.
Sponsors of clinical studies for antimicrobial drugs to treat acute bacterial sinusitis (ABS) should use superiority trials and demonstrate that the candidate affects the clinical course of the disease, according to finalized FDA guidance on the topic.
Lupin Pharmaceuticals has received final approval for its oral contraceptive Kurvelo (levonorgestrel/ethinyl estradiol tablets) 0.15 mg/0.03 mg from the FDA.
An antibiotic used to treat severe bacterial infections showed promise at treating a highly drug-resistant and deadly form of tuberculosis, U.S. government and South Korean researchers said.
In what could be a major boost to pharmaceutical companies in both countries, India and Russia are liberalizing registration of new medicines to improve trade.
Vanda Pharmaceuticals said tasimelteon, a compound under trial for the treatment in totally blind individuals, suffering from Non-24-Hour disorder, is found to restore daily cortisol rhythms.
Mexican drugmaker Neolpharma bought a Pfizer facility in Puerto Rico that was set to close at the end of this year.
Mylan agreed to buy an Indian drug manufacturing plant for about $32.5 million.
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