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 Sets Goal Date for Lymphoma Drug Columvi
December 5th 2024The combination of Columvi, gemcitabine and oxaliplatin is the first CD20xCD3 bispecific antibody to show positive results in a randomized diffuse large B-cell lymphoma phase 3 trial. The FDA’s decision is expected by July 20, 2025.
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