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FDA Actions in Brief November 2010 (Latuda, Ofirmev, Cymbalta, Botox, Pradaxa, Afinitor, Teflaro, Herceptin, Kapvay)


Recent FDA Approvals (through October 2010) related to Latuda, Ofirmev, Cymbalta, Botox, Pradaxa, Afinitor, Teflaro, Herceptin, Kapvay

Lurasidone (Latuda, Sunovion Pharmaceuticals) tablets were approved for the treatment of adults with schizophrenia.

Acetaminophen (Ofirmev, Cadence Pharmaceuticals) injection was approved for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

Duloxetine hydrochloride (Cymbalta, Eli Lilly and Co.) was approved to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower-back pain.

Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) was approved for the prevention of stroke and blood clots in patients with atrial fibrillation.

Everolimus (Afinitor, Novartis) was approved for the treatment of subependymal giant cell astrocytoma associated with tuberous sclerosis.

Ceftaroline fosamil (Teflaro, Forest) injectable antibiotic was approved to treat adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, including MRSA.

Trastuzumab (Herceptin, Genentech) was approved in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil [5-FU]) for HER2-positive metastatic stomach or gastroesophageal junction cancer, in men and women who have not received prior treatment for their metastatic disease.

Clonidine hydrochloride (Kapvay, Shionogi) was approved for the treatment of ADHD in children and adolescents aged 6 to 17 years.

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