New Recall Announced for Products Containing Valsartan
November 28th 2018Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine/Valsartan combination tablets and Amlodipine Valsartan/Hydrochlorothiazide combination tablets, due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India.
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FDA Grants Onc Drug Accelerated Approval for Key Genetic Driver of Cancer
November 27th 2018The FDA has granted an accelerated approval to larotrectinib (Vitrakvi, Loxo Oncology) for the treatment of adult and pediatric patients with solid tumors that have an NTRKgene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
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FDA OKs Autoinjector Formulation for Tocilizumab
November 26th 2018Officials with the FDA have approved Genentech’s single-dose, prefilled autoinjector ACTPen 162 mg/0.9 mL for tocilizumab (Actemra) for patients with rheumatoid arthritis (RA), giant cell arteritis (GCA), and 2 forms of juvenile arthritis.
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