New Drug Approvals Archive

Get news by email or subscribe to our news feeds.

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 (Influenza Virus Vaccine) FDA Approval History

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 (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 (vorinostat) FDA Approval History

October 6

Risperdal (risperidone)

New Indication Approved: October 6, 2006

October 11

Avastin (bevacizumab)

New Indication Approved: October 11, 2006

Avastin (bevacizumab) FDA Approval History

October 12

Nexium (esomeprazole)

New Indication Approved: October 11, 2006

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 (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 (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 (ciclesonide) FDA Approval History

October 23

Seroquel (quetiapine)

New Indication Approved: October 20, 2006

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 (telbivudine) FDA Approval History

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.

ArteFill (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.

Veregen (kunecatechins) FDA Approval History

Hide
(web2)