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
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
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FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
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