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FDA actions in brief, July 2009 (Besivance, Taxus Liberte Atom Stent System, Risperdal Consta, Prograf, Zipsor, Sprycel, Axert, Caldolor, Lamictal XR)


Recent FDA approvals (through July 2009) related to Besivance, Taxus Liberte Atom Stent System, Risperdal Consta, Prograf, Zipsor, Sprycel, Axert, Caldolor, and Lamictal XR

Besifloxacin ophthalmic suspension 0.6% (Besivance, Bausch & Lomb) was approved for the treatment of bacterial conjunctivitis.

A paclitaxel-eluting coronary stent system (Taxus Liberte Atom Stent System, Boston Scientific) was approved for the treatment of small-vessel coronary artery disease.

Risperidone long-acting treatment (Risperdal Consta, Janssen) was approved as both monotherapy and as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder.

A liquid-filled capsule formulation of diclofenac (Zipsor, Xanodyne) was approved for the relief of mild-to-moderate acute pain in adult patients. The accelerated approval for dasatinib (Sprycel, Bristol-Myers Squibb) for the treatment of adult patients in all phases of chronic myeloid leukemia with resistance or intolerance to previous therapy, including imatinib, was converted to a full approval.

Almotriptan (Axert, Almirall) was approved for the acute treatment of migraine headache in adolescent patients aged 12 to 17 years.

An intravenous formulation of ibuprofen (Caldolor, Cumberland) was approved as an adjunct to opioid analgesics for the management of mild-to-moderate and moderate-to-severe pain and for the reduction of fever in adult patients.

Extended-release lamotrigine tablets (Lamictal XR, GlaxoSmithKline) were approved as adjunctive therapy for partial-onset seizures with or without secondary generalization in patients aged ≥13 years.

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