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New Drug Approvals Archive - 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.

Read more: Divigel (estradiol) FDA Approval History

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.

Read more: Extina (ketoconazole) FDA Approval History

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.

Read more: Letairis (ambrisentan) FDA Approval History

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).

Read more: Nuvigil (armodafinil) FDA Approval History

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.

Read more: Exforge (amlodipine and valsartan) FDA Approval History

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.

Read more: Endometrin (progesterone) FDA Approval History

New Drug Approvals Archive