New Drug Approvals Archive - October 2006

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

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

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

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

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

Tyzeka (telbivudine) Tablets

Date of Approval: October 25, 2006
Company: Novartis
Treatment for: Chronic Hepatitis B

Marketing Status: Discontinued

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

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

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