FDA Actions in Brief May 2010 (Zortress, OxyContin, Exalgo, Kaletra, Provenge, Dacogen, Asclera, Pancreaze, Tarceva, Oravig)


Recent FDA approvals (through April 2010) related to Zortress, OxyContin, Exalgo, Kaletra, Provenge, Dacogen, Asclera, Pancreaze, Tarceva, Oravig

Everolimus (Zortress, Novartis) oral tablets for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk.

Reformulated oxycodone HCl controlled-release tablets (OxyContin, Purdue Pharma) in an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse.

Hydromorphone HCl extended-release tablets (Exalgo, CombinatoRx/Mallinckrodt) for managing moderate-to-severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period.

Sipuleucel-T (Provenge, Dendreon) for the treatment of men with advanced prostate cancer.

Decitabine (Dacogen, Eisai) for injection 5-day dosing regimen to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.

Polidocanol (Asclera, BioForm Medical, Chemische Fabrik Kreussler) injection for the treatment of small types of abnormally swollen or twisted veins called varicose veins.

Pancrelipase delayed-release capsules (Pancreaze, Johnson & Johnson Pharmaceutical Research and Development) for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Exocrine pancreatic insufficiency is the inability to properly digest and absorb food due to a lack of enzymes made by the pancreas that are important in the digestion of fats, proteins, and sugars.

Erlotinib (Tarceva, Genentech and OSI Pharmaceuticals) as a maintenance treatment for patients with locally advanced or metastatic non-small cell lung cancer whose disease has not progressed after 4 cycles of platinum-based first-line chemotherapy.

Miconazole (Oravig, Strativa) buccal tablets for the treatment of oropharyngeal candidiasis in adults and children older than age 16.

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