New Drug Approvals Archive
New Drug Approvals: October 2006
| October 4 | Yaz (drospirenone and ethinyl estradiol) Tablets Company: Berlex, Inc. Treatment for Acne Yaz Acne - Treatment for Prevention of Pregnancy, Premenstrual Dysphoric Disorder |
| October 5 | FluLaval (Influenza Virus Vaccine) Date of Approval: October 5, 2006 Company: GlaxoSmithKline Treatment for Influenza Prophylaxis FluLaval 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 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 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 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 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 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 is a synthetic thymidine nucleoside analogue indicated for the treatment of chronic hepatitis B. Tyzeka Novartis - Treatment for Chronic Hepatitis B |
| October 30 | 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 Genital and Perianal Warts Veregen 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 |
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