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Recent FDA action (through January 2013) related to, IPX066, Afatinib, Enobosam, GTx-024, Elafin, Ezatiostat HCL, Tranexamic acid tablets, Lamotrigine extended-release tablets

Complete response

  • IPX066 (Rytary, Impax Pharmaceuticals, a division of Impax Laboratories) extended-release capsule formulation of carbidopa-levodopa, for the symptomatic treatment of Parkinson’s disease. The complete response letter (CRL) indicated that FDA requires a satisfactory re-inspection of the company’s Hayward, Calif. facility as a result of the warning letter issued in May 2011 before the company’s NDA may be approved due to the facility’s involvement in the development of Rytary, and supportive manufacturing and distribution activities. During the assessment of the NDA, the company withdrew the Hayward site as an alternative site of commercial production at launch. The company said it will work with FDA on the appropriate next steps for the Rytary application.

Fast-track designation

  • Afatinib (Boehringer Ingelheim) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with an epidermal growth factor receptor mutation as detected by an FDA-approved test.

Priority review

  • Enobosarm, GTx-024 (GTx) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.

Orphan drug designations

  • Elafin (Proteo) for the treatment of pulmonary arterial hypertension.

  • Ezatiostat HCL (Telintra, Telik), for the treatment of myelodysplastic syndrome.

First-time generic approvals

Tranexamic acid tablets (equiv to Lysteda)

Lamotrigine extended-release tablets in 25-mg, 50-mg, 100-mg, 200-mg, and 300-mg strengths (equiv to Lamictal XR)


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