FDA actions in brief, November 2009 (FluMist, Cervarix, Gardasil, Fluarix, Folotyn, Micardis, Twynsta, Votrient, Mirena)


Recent FDA approvals (through November 2009) related to FluMist, Cervarix, Gardasil, Fluarix, Folotyn, Micardis, Twynsta, Votrient, Mirena

Injectable monovalent vaccines (CSL Limited, Novartis, Sanofi Pasteur) and an intranasal spray monovalent vaccine (FluMist, MedImmune) were approved for the prevention of influenza A (H1N1) virus.

Prophylactic human papillomavirus (HPV) vaccine (Cervarix, GlaxoSmithKline Biologicals) was approved for the prevention of cervical cancer and precancerous lesions caused by HPV types 16 and 18 in girls and women aged 10 to 25 years.

Recombinant human papillomavirus (HPV) quadrivalent vaccine (Gardasil, Merck) was approved for the prevention of genital warts caused by HPV types 6 and 11 in boys and young men aged 9 to 26 years.

Pralatrexate injection (Folotyn, Allos Therapeutics) was granted accelerated approval for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.

Telmisartan (Micardis, Boehringer Ingelheim Pharmaceuticals) tablets 80 mg were approved for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients aged 55 years or more at high risk of developing major cardiovascular events who are unable to take angiotensin-converting enzyme inhibitors.

Telmisartan/amlodipine (Twynsta, Boehringer Ingelheim Pharmaceuticals) tablets were approved as a new combination for the treatment of hypertension alone or in combination with other anti-hypertensive agents, or as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals.

Pazopanib (Votrient, GlaxoSmithKline) was approved to treat advanced renal cell carcinoma.

Levonorgestrel-releasing intrauterine system (Mirena, Bayer HealthCare Pharmaceuticals) was approved for additional use to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention.

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