New Drug Approvals Archive - November 2004

TriCor (fenofibrate) Tablets

Date of Approval: November 5, 2004
Company: Abbott Laboratories
Treatment for: Hyperlipoproteinemia Type IIa (Elevated LDL), Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL), Hyperlipoproteinemia, Hyperlipoproteinemia Type IV (Elevated VLDL), Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL), Hypertriglyceridemia

TriCor (fenofibrate tablets) is a lipid regulating agent indicated for the treatment of hypercholesterolemia and hypertriglyceridemia.

• TriCor Abbott Laboratories - Treatment for Lipid Disorders

TriCor (fenofibrate) FDA Approval History

Omacor (omega-3-acid ethyl esters) Capsules

Date of Approval: November 10, 2004
Company: Reliant Pharmaceuticals, Inc.
Treatment for: Hypertriglyceridemia

Omacor (omega-3 polyunsaturated fatty acids) is indicated as an adjunct to diet for the reduction of triglycerides in adult patients with very high triglyceride levels.

• Omacor Reliant Pharmaceuticals, Inc. - Treatment for Hypertriglyceridemia

Omacor (omega-3-acid ethyl esters) FDA Approval History

Tarceva (erlotinib) Tablets

Date of Approval: November 18, 2004
Company: OSI/Genentech
Treatment for: Non-Small Cell Lung Cancer, Pancreatic Cancer

Tarceva (erlotinib) is a kinase inhibitor indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) and for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.

• FDA Approves Tarceva (erlotinib) for Non-Small Cell Lung Cancer (NSCLC)

Tarceva (erlotinib) FDA Approval History

VESIcare (solifenacin) Tablets

Date of Approval: November 19, 2004
Company: Yamanouchi / GlaxoSmithKline
Treatment for: Overactive Bladder

VESIcare (solifenacin) is a muscarinic receptor antagonist treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

• Vesicare Yamanouchi / GlaxoSmithKline - Treatment for Overactive Bladder

VESIcare (solifenacin) FDA Approval History

Tysabri (natalizumab) Injection - formerly Antegren

Date of Approval: November 23, 2004
Company: Biogen Idec / Elan Corporation, plc
Treatment for: Multiple Sclerosis, Crohn's Disease -- Maintenance

Tysabri (natalizumab) is a recombinant humanized IgG4κ monoclonal antibody for the treatment of multiple sclerosis and Crohn's disease.

• Tysabri Approved for Multiple Sclerosis

Tysabri (natalizumab) FDA Approval History

Combunox (ibuprofen and oxycodone hydrochloride) Tablets

Date of Approval: November 26, 2004
Company: Forest Laboratories, Inc.
Treatment for: Pain

Combunox (ibuprofen and oxycodone hydrochloride) is a nonsteroidal anti-inflammatory drug (NSAID) and opioid combination indicated for the short-term management of acute, moderate to severe pain.

• Combunox Forest Laboratories, Inc. - Treatment for Moderate to Severe Pain

Combunox (ibuprofen and oxycodone hydrochloride) FDA Approval History

Nexium (esomeprazole)

New Indication Approved: November 24, 2004

• Nexium approved for reduced risk of stomach ulcer development among NSAID users

Antara (fenofibrate) Capsules

Date of Approval: November 30, 2004
Company: Reliant Pharmaceuticals, Inc.
Treatment for: Hypertriglyceridemia, Heterozygous Familial Hypercholesterolemia

Antara (fenofibrate) is a lipid-lowering agent approved as adjunctive therapy to diet for the treatment of elevated levels of cholesterol and triglycerides.

• Antara Reliant Pharmaceuticals, Inc. - Treatment for Hypercholesterolemia and Hypertriglyceridemia

Antara (fenofibrate) FDA Approval History

Clindesse (clindamycin phosphate) Vaginal Cream

Date of Approval: November 30, 2004
Company: KV Pharmaceutical Company
Treatment for: Bacterial Vaginosis

Clindesse (clindamycin) Vaginal Cream is a single-dose topical antibiotic therapy indicated to treat bacterial vaginosis.

• Clindesse KV Pharmaceutical Company - Treatment for Bacterial Vaginosis

Clindesse (clindamycin phosphate) FDA Approval History

Captique (dermal filler) Injectable Gel

Date of Approval: November 12, 2004
Company: Inamed Corp / Genzyme Corp
Treatment for: Wrinkle Correction

Captique is a non-animal stabilized hyaluronic acid dermal filler indicated for the correction of moderate to severe facial wrinkles.

• Captique Inamed Corp / Genzyme Corp - Treatment for Facial Wrinkle Correction

Captique (dermal filler) FDA Approval History

Tysabri (natalizumab)

New Indication Approved: January 14, 2008

• FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease

Tysabri (natalizumab) 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