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New Drug Approvals Archive - April 2010

April 2010

April 6

OxyContin (oxycodone)

New Formulation Approved: April 5, 2010

April 12

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.

Pancreaze (pancrelipase) FDA Approval History

April 16

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.

Oravig (miconazole) FDA Approval History

April 18

Tarceva (erlotinib)

New Indication Approved: April 16, 2010

Tarceva (erlotinib) FDA Approval History

April 19

Privigen (immune globulin intravenous (human))

Labeling Revision Approved: April 19, 2010

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

April 22

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.

Zortress (everolimus) FDA Approval History

April 28

Kaletra (lopinavir and ritonavir)

New Dosage Regimen: April 27, 2010

April 29

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.

Provenge (sipuleucel-T) FDA Approval History

April 30

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.

Vimovo (naproxen and esomeprazole magnesium) FDA Approval History

New Drug Approvals Archive