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FDA Pipeline preview, June 2008


Recent FDA action (through June 2008) related to lucinactant, loratadine/montelukast, niacin/laropiprant, fentanyl buccal, NPL-2008, carfilzomib, resveratrol, and rhitol.

Approvable designation

•Lucinactant (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome in premature infants (third approvable letter)

Recommended for approval

Nonapprovable designations

•Loratadine/montelukast combination (Schering-Plough/Merck) for the treatment of allergic rhinitis symptoms

•Extended-release niacin/laropiprant (MK-0524A, Merck) for the treatment of primary hypercholesterolemia or mixed dyslipidemia

•Icatibant (Jerini) for the treatment of hereditary angioedema

Not recommended for approval

•Fentanyl buccal tablet (Fentora, Cephalon) for the management of breakthrough pain in opioid- tolerant patients with chronic pain conditions

Fast-track designation

•NPL-2008 (Neuropharm) for the treatment of autism disorder

Orphan drug designations

•Carfilzomib (Proteolix) for the treatment of multiple myeloma

•Resveratrol (Sirtris) for the treatment of mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-like episodes (MELAS) syndrome

•Aerosolized alpha-1 antitrypsin (Kamada) for the treatment of bronchiectasis

•Rhitol (Kiadis) for the treatment of chronic graft-versus-host disease

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