New Drug Approvals Archive
New Drug Approvals: June 2007
| June 4 | 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. FDA Approves Divigel (estradiol gel) 0.1 Percent for Treatment of Moderate to Severe Hot Flashes Associated with Menopause |
| June 12 | 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. FDA Approves Extina for the Treatment of Seborrheic Dermatitis |
| June 15 | Apidra (insulin glulisine)
New Dosage Regimen: April 12, 2007 FDA Approves New Route of Administration for Rapid-Acting Apidra Providing an Additional Treatment Option for Hospitalized Diabetes Patients with High Blood Sugar Levels |
| June 15 | 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. U.S. Food and Drug Administration Approves Gilead's Letairis (ambrisentan) 5 mg and 10 mg Tablets for the Once-Daily Treatment of Pulmonary Arterial Hypertension (WHO Group 1) in Patients with WHO Functional Class II or III Symptoms |
| June 15 | 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). Cephalon Receives FDA Approval of Nuvigil for the Treatment of Excessive Sleepiness Associated with Three Disorders |
| June 20 | 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. Exforge Receives Final US Approval as New and Powerful Treatment Option for Patients With High Blood Pressure |
| June 21 | 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. FDA Approves Ferring Pharmaceuticals' Endometrin for Luteal Phase Support in Assisted Reproductive Technology Treatment |
| August 4 | Exforge (amlodipine and valsartan)
New Indication Approved: July 23, 2008 Single-Pill Combinations Diovan HCT and Exforge Approved in US as First-Line Treatments for High Blood Pressure |
New Drug Approvals Archive
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