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New Drug Approvals Archive - June 2007

See also: New Indications and Dosage Forms for June 2007

June 2007

Divigel (estradiol) Gel

Date of Approval: June 4, 2007
Treatment for: Postmenopausal Symptoms

Divigel (estradiol) is a low dose topical estrogen gel, which is applied to the skin of the thigh once daily for the treatment of moderate to severe hot flashes associated with menopause.

Extina (ketoconazole) Foam

Date of Approval: June 12, 2007
Company: Stiefel Laboratories, Inc.
Treatment for: Seborrheic Dermatitis

Extina Foam is a topical formulation of the antifungal ketoconazole in VersaFoam for the treatment of seborrheic dermatitis.

Letairis (ambrisentan) Tablets

Date of Approval: June 15, 2007
Company: Gilead Sciences, Inc.
Treatment for: Pulmonary Hypertension

Letairis (ambrisentan) is an endothelin receptor antagonist (ERA) indicated for the once-daily oral treatment of pulmonary arterial hypertension.

Nuvigil (armodafinil) Tablets

Date of Approval: June 15, 2007
Company: Cephalon, Inc.
Treatment for: Narcolepsy

Nuvigil (armodafinil) is a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder (SWSD).

Exforge (amlodipine and valsartan) Tablets

Date of Approval: June 20, 2007
Company: Novartis
Treatment for: Hypertension

Exforge is a single-tablet combination of an angiotensin receptor blocker (valsartan) and a calcium channel blocker (amlodipine) taken once-daily for the treatment of hypertension.

Endometrin (progesterone) Vaginal Insert

Date of Approval: June 21, 2007
Company: Ferring Pharmaceuticals, Inc.
Treatment for: Female Infertility

Endometrin is a progesterone vaginal insert indicated to support embryo implantation and early pregnancy as part of an Assisted Reproductive Technology (ART) treatment for infertile women.

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