New Drug Approvals Archive - April 2010
New Formulation Approved: April 5, 2010
Pancreaze (pancrelipase) Delayed-Release Capsules
Date of Approval: April 12, 2010
Company: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Treatment for: Pancreatic Exocrine Dysfunction
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
Company: BioAlliance Pharma SA
Treatment for: Oral Thrush
Oravig (miconazole) is a mucoadhesive buccal azole antifungal therapy indicated for the local treatment of oropharyngeal candidiasis in adults.
Read more: Oravig (miconazole) FDA Approval History
New Indication Approved: April 16, 2010
Read more: Tarceva (erlotinib) FDA Approval History
Privigen (immune globulin intravenous (human))
Labeling Revision Approved: April 19, 2010
Zortress (everolimus) Tablets - formerly Certican
Date of Approval: April 22, 2010
Company: Novartis Pharma AG
Treatment for: Organ Transplant -- Rejection Prophylaxis
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.
- Novartis Receives US FDA Approval for Zortress (everolimus) to Prevent Organ Rejection in Adult Kidney Transplant Recipients
Read more: Zortress (everolimus) FDA Approval History
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
Company: Dendreon Corporation
Treatment for: Prostate Cancer
Provenge (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
Read more: Provenge (sipuleucel-T) FDA Approval History
Vimovo (naproxen and esomeprazole magnesium) - formerly PN 400
Date of Approval: April 30, 2010
Company: Pozen Inc. and AstraZeneca
Treatment for: Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, NSAID-Induced Ulcer Prophylaxis
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.