Washington Drug Letter

FDA investigators and local police on Oct. 16, raided the Framingham, Mass., facilities of the compounding pharmacy whose steroid injections are linked to a recent fungal meningitis outbreak.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 9–6 Thursday to recommend approval of Genzyme and Isis Pharmaceuticals’ homozygous familial hypercholesterolemia (HoFH) drug Kynamro.

Despite liver toxicity concerns, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13–2 to recommend approval of Aegerion Pharmaceuticals’ lomitapide.

The NIH is launching an online database of about 700 prescription and OTC drugs that will automatically forward cases of drug-induced liver damage to the FDA’s MedWatch adverse event reporting program.

The FDA has approved a new indication for Celgene’s Abraxane in combo with carboplatin as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) for patients who can’t undergo surgery or radiation therapy.

The FDA has revised and clarified a final ICH question-and-answer guidance on the evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.

The FDA has issued an untitled letter to Genentech for educational aids aimed at healthcare professionals that overstate the efficacy and minimize the risks of its cancer drug Tarceva.

The FDA has granted a priority review to Genentech’s sBLA for Avastin in people with metastatic colorectal cancer (mCRC) who have already been treated with chemotherapy plus Avastin.

An FDA advisory panel voted 12–0 Tuesday to recommend approval of NPS Pharmaceuticals’ Gattex as a treatment for short bowel syndrome (SBS).