New Drug Approvals Archive - April 2010
New Formulation Approved: April 5, 2010
Pancreaze (pancrelipase) Delayed-Release Capsules
Date of Approval: April 12, 2010
Pancreaze (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
Oravig (miconazole) Buccal Tablets - formerly Loramyc
Date of Approval: April 16, 2010
Oravig (miconazole) is a mucoadhesive buccal azole antifungal therapy indicated for the local treatment of oropharyngeal candidiasis in adults.
New Indication Approved: April 16, 2010
Privigen (immune globulin intravenous (human))
Labeling Revision Approved: April 19, 2010
Zortress (everolimus) Tablets - formerly Certican
Date of Approval: April 22, 2010
Zortress (everolimus) is an oral inhibitor of the mTOR pathway indicated for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk.
Kaletra (lopinavir and ritonavir)
New Dosage Regimen: April 27, 2010
Provenge (sipuleucel-T) Suspension for Intravenous Infusion - formerly APC8015
Date of Approval: April 29, 2010
Provenge (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
Vimovo (naproxen and esomeprazole magnesium) - formerly PN 400
Date of Approval: April 30, 2010
Vimovo is a combination of the pain reliever naproxen (NSAID) and esomeprazole magnesium (proton pump inhibitor) indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.