New Drug Approvals Archive

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November 2004

November 5

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 (fenofibrate) FDA Approval History

November 10

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

November 18

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.

Tarceva (erlotinib) FDA Approval History

November 18

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.

Tarceva (erlotinib) FDA Approval History

November 19

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 (solifenacin) FDA Approval History

November 23

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 (natalizumab) FDA Approval History

November 26

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 (ibuprofen and oxycodone hydrochloride) FDA Approval History

November 29

Nexium (esomeprazole)

New Indication Approved: November 24, 2004

November 30

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 (fenofibrate) FDA Approval History

November 30

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 (clindamycin phosphate) FDA Approval History

November 12

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 (dermal filler) FDA Approval History

January 15

Tysabri (natalizumab)

New Indication Approved: January 14, 2008

Tysabri (natalizumab) FDA Approval History

April 18

Tarceva (erlotinib)

New Indication Approved: April 16, 2010

Tarceva (erlotinib) FDA Approval History

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