New Drug Approvals Archive - June 2007

Norditropin (somatropin [rDNA origin])

New Indication Approved: May 31, 2007

• FDA Approves Norditropin for Treatment of Short Stature Associated with a Rare Genetic Disorder

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

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.

• FDA Approves Extina for the Treatment of Seborrheic Dermatitis

Extina (ketoconazole) FDA Approval History

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

Apidra (insulin glulisine) 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.

• 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

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).

• Cephalon Receives FDA Approval of Nuvigil for the Treatment of Excessive Sleepiness Associated with Three Disorders

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.

• Exforge Receives Final US Approval as New and Powerful Treatment Option for Patients With High Blood Pressure

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.

• FDA Approves Ferring Pharmaceuticals' Endometrin for Luteal Phase Support in Assisted Reproductive Technology Treatment

Endometrin (progesterone) FDA Approval History

Lyrica (pregabalin)

New Indication Approved: June 21, 2007

• FDA Approves First Drug for Treating Fibromyalgia - Lyrica

Lyrica (pregabalin) FDA Approval History

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

Exforge (amlodipine and valsartan) FDA Approval History

Letairis (ambrisentan)

Labeling Revision Approved: October 2, 2015

• FDA Approves New Treatment Combination of Gilead’s Letairis with Tadalafil for Pulmonary Arterial Hypertension (WHO Group 1)

Letairis (ambrisentan) FDA Approval History