Recent FDA action (through April 2008) related to Rotavirus vaccine, live, oral; istradefylline; olanzapine long-acting injection; mycobacterial cell wall-DNA complex; talactoferrin; levodopa/carbidopa intestinal gel; prasugrel; eltrombopag; difluprednate ophthalmic emulsion; EUR-1008; ARG201; MGCD0103; triphendiol; ADH-1; and levofloxacin solution for inhalation.
Recommended for approval
• Rotavirus vaccine, live, oral (Rotarix, GlaxoSmithKline) to prevent rotavirus gastroenteritis in infants
Nonapprovable designations
• Olanzapine long-acting injection (Zyprexa, Eli Lilly) for the treatment and maintenance therapy of schizophrenia in adult patients
Fast-track designations
• Mycobacterial cell wall-DNA complex (Urocidin, Bioniche Life Sciences) for the first-line treatment of non-muscle-invasive bladder cancer
• Talactoferrin (Agennix) as monotherapy for the treatment of patients with non-small cell lung cancer (NSCLC) in whom ≥2 previous therapies have failed
• Levodopa/carbidopa intestinal gel (Duodopa, Solvay) for the long-term treatment of motor fluctuations associated with advanced PD
Priority review
• Prasugrel (Daiichi Sankyo/Eli Lilly) for the treatment of acute coronary syndrome (ACS) in patients undergoing percutaneous coronary intervention (PCI)
• Eltrombopag (Promacta, GlaxoSmithKline) for the short-term treatment of chronic idiopathic thrombocytopenic purpura (ITP)
• Difluprednate ophthalmic emulsion (Durezol, Sirion) for the treatment of postoperative ocular inflammation
• EUR-1008 (Zentase, Eurand) for the treatment of pancreatic insufficiency
Orphan drug designations
• ARG201 (arGentis) for the treatment of diffuse systemic sclerosis (systemic scleroderma)
• MGCD0103 (Pharmion/MethylGene) for the treatment of acute myelogenous leukemia (AML)
• Triphendiol (Marshall Edwards) for the treatment of stage IIB through stage IV malignant melanoma
• ADH-1 (Adherex Technologies) in combination with melphalan for the treatment of stage IIB/C, III, and IV malignant melanoma
• Levofloxacin solution for inhalation (Mpex) for the treatment of pulmonary infections caused by Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis
FDA and EMA Accepts Applications for New Nusinersen Regimen
January 23rd 2025An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.
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