New Drug Approvals Archive - April 2010

OxyContin (oxycodone)

New Formulation Approved: April 5, 2010

• FDA Approves New Formulation for OxyContin

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.

• FDA Approves Pancreatic Enzyme Product, Pancreaze

Pancreaze (pancrelipase) FDA Approval History

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.

• FDA Approves Oravig (miconazole) Buccal Tablets for Treatment of Oropharyngeal Candidiasis

Oravig (miconazole) FDA Approval History

Tarceva (erlotinib)

New Indication Approved: April 16, 2010

• FDA Approves Tarceva as a Maintenance Therapy for Advanced Non-Small Cell Lung Cancer

Tarceva (erlotinib) FDA Approval History

Privigen (immune globulin intravenous (human))

Labeling Revision Approved: April 19, 2010

• CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen from 24 to 36 Months

Privigen (immune globulin intravenous (human)) FDA Approval History

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

Zortress (everolimus) FDA Approval History

Kaletra (lopinavir and ritonavir)

New Dosage Regimen: April 27, 2010

• Abbott Receives FDA Approval for Once-Daily Dosing of Kaletra (lopinavir / ritonavir) for Treatment-Experienced Patients

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.

• FDA Approves Provenge - a Cellular Immunotherapy for Men With Advanced Prostate Cancer

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.

• FDA Approved Vimovo for Arthritis Patients At Risk of Developing NSAID-Associated Gastric Ulcers

Vimovo (naproxen and esomeprazole magnesium) FDA Approval History