New Drug Approvals Archive

New Drug Approvals: October 2006

October 5
FluLaval (Influenza Virus Vaccine)

Date of Approval: October 5, 2006

Company: GlaxoSmithKline

Treatment for: Influenza Prophylaxis

FluLaval (Influenza Virus Vaccine) is indicated for the active immunization of adults 18 years and older against influenza disease caused by influenza virus types A and B contained in the vaccine.

FluLaval GlaxoSmithKline - Treatment for Prevention of Influenza
 
October 6
Brovana (arformoterol tartrate) Inhalation Solution

Date of Approval: October 6, 2006

Company: Sepracor Inc.

Treatment for: Chronic Obstructive Pulmonary Disease

Brovana (arformoterol tartrate) is a long-acting beta2-agonist for inhalation via a nebulizer, used for the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Brovana Sepracor Inc. - Treatment for Chronic Obstructive Pulmonary Disease
 
October 6
Zolinza (vorinostat) Capsules

Date of Approval: October 6, 2006

Company: Merck & Co., Inc.

Treatment for: Cutaneous T-cell Lymphoma

Zolinza (vorinostat) is a histone deacetylase (HDAC) inhibitor for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL), a form of non-Hodgkin's lymphoma, who have progressive, persistent or recurrent disease on or following two systemic therapies.

Zolinza Merck & Co., Inc. - Treatment for Cutaneous T-cell Lymphoma
 
October 6
Risperdal (risperidone)

New Indication Approved: October 6, 2006

FDA Approves Risperdal to Treat Irritability Associated with Autism
 
October 11
Avastin (bevacizumab)

New Indication Approved: October 11, 2006

FDA Approves Avastin in Combination With Chemotherapy for First-Line Treatment of Most Common Type of Lung Cancer
 
October 12
Nexium (esomeprazole)

New Indication Approved: October 11, 2006

FDA Approves Nexium for the Treatment of Zollinger-Ellison Syndrome
 
October 17
Januvia (sitagliptin phosphate) Tablets

Date of Approval: October 17, 2006

Company: Merck & Co., Inc.

Treatment for: Diabetes Mellitus Type II

Januvia (sitagliptin phosphate) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Januvia Merck & Co., Inc. - Treatment for Type 2 Diabetes
 
October 20
Desonate (desonide) Gel

Date of Approval: October 20, 2006

Company: SkinMedica, Inc.

Treatment for: Dermatitis

Desonate (desonide) is a low potency topical steroid formulated in a proprietary water- based Hydrogel vehicle indicated for the treatment of mild to moderate atopic dermatitis.

Desonate SkinMedica, Inc. - Treatment for Atopic Dermatitis
 
October 20
Omnaris (ciclesonide) Nasal Spray

Date of Approval: October 20, 2006

Company: Altana Pharma

Treatment for: Allergic Rhinitis

Omnaris (ciclesonide) is an intranasal corticosteroid indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 12 years of age and older.

Omnaris Altana Pharma - Treatment for Allergic Rhinitis
 
October 23
Seroquel (quetiapine)

New Indication Approved: October 20, 2006

FDA Approves AstraZeneca's Seroquel For Bipolar Depression Treatment
 
October 25
Tyzeka (telbivudine) Tablets

Date of Approval: October 25, 2006

Company: Novartis

Treatment for: Chronic Hepatitis B

Tyzeka (telbivudine) is a synthetic thymidine nucleoside analogue indicated for the treatment of chronic hepatitis B.

Tyzeka Novartis - Treatment for Chronic Hepatitis B
 
October 27
ArteFill (dermal filler)

Date of Approval: October 27, 2006

Company: Artes Medical, Inc.

Treatment for: Facial Wrinkles

ArteFill is a dermal filler indicated for the correction of nasolabial folds, or smile lines.

FDA Approves ArteFill as the First Non-Resorbable Injectable Wrinkle Filler to Correct Smile Lines
 
October 31
Veregen (kunecatechins) Ointment - formerly Polyphenon E

Date of Approval: October 31, 2006

Company: MediGene AG

Treatment for: Condylomata Acuminata

Veregen(kunecatechins) contains a concentrate of catechines extracted from green tea leaves. Veregen is indicated for the treatment of external genital and perianal warts.

Polyphenon E MediGene AG - Treatment for Genital and Perianal Warts
 

New Drug Approvals Archive

2009: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov
2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Jan | Feb | Jul | Aug | Oct | Nov | Dec

MedNotes
Advertisement

(web3)