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
Iowa Expands PBM Legislation to Address Concerns of Independent Pharmacies
May 16th 2025A new law in Iowa, if signed by the governor, will mandate 100% pass-through of rebates, increased financial transparency, and a minimal payment for pharmacies. Critics say it will be the most costly mandate in the state’s history.
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May 9th 2025It could improve access to community pharmacies and lower prices. Or it will limit access to critical drugs and impact payers’ ability to contract for a broad range of services. Industry leaders are unsure about the impact of Arkansas’ law banning PBMs from owning pharmacies.
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