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New Drug Approvals Archive - April 2010

See also: New Indications and Dosage Forms for April 2010

April 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.

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.

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.

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.

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