New Drug Approvals Archive - October 2006

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.

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.

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.

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.

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.

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.

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.

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.