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
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
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