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September 1, 2012

Recent FDA action (through August 2012) related to, ferric carboxymaltose injection, Injectafer, abiraterone acetate, Zytiga, cabozantinib, Exelixis, eltrombopag, Promacta, AEZS-130 oral ghrelin agonist, inhaled nitric oxide, GeNO LLC, gevokizumab, XOMA, calcipotriene cream, Dovonex, montelukast sodium, Singulair, lidocaine topical patch 5%, Lidoderm, filgrastim, Neupogen

Complete response

■ Ferric carboxymaltose injection (Injectafer, Luitpold Pharmaceuticals) for the treatment of iron deficiency anemia. In the complete response letter (CRL) FDA said that its decision to withhold approval at this time was not related to any issues with the Injectafer NDA filing, but with Luitpold's manufacturing facility in Shirley, N.Y. During a recent inspection, issues in the manufacturing facility were noted by FDA inspectors. This is the same facility that is to be used to manufacture Injectafer for the US market. The company is working with FDA to resolve the issues found in FDA's recent inspection. Luitpold believes it has adequately responded to all the clinical questions concerning Injectafer raised by FDA during the current review period.

Priority review

■ Cabozantinib (Exelixis), a potent dual inhibitor of the MET and VEGF pathways designed to block MET-driven tumor escape, for the treatment of an advanced form of medullary thyroid cancer.

■ Eltrombopag (Promacta, Ligand Pharmaceuticals and GlaxoSmithKline) thrombopoeitin receptor agonist for the treatment of thrombocytopenia in patients with chronic hepatitis C virus infection.

■ AEZS-130 oral ghrelin agonist (Aeterna Zentaris) as a diagnostic test for adult growth hormone deficiency.

Orphan drug designations

■ Inhaled nitric oxide (GeNO LLC) (delivered via the GeNOsyl MVG-2000 delivery system) for the treatment of pesistent pulmonary hypertension in newborns.

■ Gevokizumab (XOMA) IL-1 beta modulating antibody for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis.

First-time generic approvals

Calcipotriene cream (equiv to Dovonex)
SANDOZ

Montelukast sodium (equiv to Singulair) tablets
APOTEX, AUROBINDO PHARMA, ENDO PHARMACEUTICALS, GLENMARK GENERICS, KUDCO IRELAND, MYLAN, ROXANE LABORATORIES, SANDOZ, TEVA, AND TORRENT

Montelukast sodium (equiv to Singulair) chewable tablets
APOTEX, AUROBINDO, ENDO, KUDCO, MYLAN, ROXANE, SANDOZ, TEVA, AND TORRENT

Montelukast sodium (equiv to Singulair) oral granule form
TEVA

Lidocaine topical patch 5% (equiv to Lidoderm)
WATSON

Filgrastim (equiv to Neupogen)
TEVA