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New Drug Approvals Archive - October 2006

October 2006

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 Brovana (arformoterol tartrate) FDA Approval History
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 Zolinza (vorinostat) FDA Approval History
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 Avastin (bevacizumab) FDA Approval History
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 Type 2 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 Januvia (sitagliptin phosphate) FDA Approval History
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 Desonate (desonide) FDA Approval History
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 Omnaris (ciclesonide) FDA Approval History
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 Tyzeka (telbivudine) FDA Approval History
October 27	Bellafill (dermal filler) Injection - formerly ArteFill Date of Approval: October 27, 2006 Company: Suneva Medical, Inc. Treatment for: Facial Wrinkles; Acne Scars Bellafill is a dermal filler indicated for the correction of nasolabial folds (smile lines) and for the treatment of acne scars. FDA Approves ArteFill as the First Non-Resorbable Injectable Wrinkle Filler to Correct Smile Lines Bellafill (dermal filler) FDA Approval History
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 Veregen (kunecatechins) FDA Approval History
December 1	Bellafill (dermal filler) New Dosage Form Approved: December 1, 2014 Treatment for: Facial Wrinkles; Acne Scars Bellafill to Replace ArteFill as New Brand Bellafill (dermal filler) FDA Approval History
January 6	Bellafill (dermal filler) New Indication Approved: December 23, 2014 Treatment for: Facial Wrinkles; Acne Scars Bellafill Receives FDA Approval for the Treatment of Acne Scars Bellafill (dermal filler) FDA Approval History

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