New Drug Approvals Archive

New Drug Approvals: June 2007

June 1 FDA Approves Norditropin for Treatment of Short Stature Associated with a Rare Genetic Disorder
 
June 5
Divigel (estradiol) Gel

Date of Approval: June 4, 2007

Treatment for Postmenopausal Symptoms

Divigel 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 6 Copaxone Pre-Filled Syringe Can Now Be Stored for up to One Month at Room Temperature
 
June 13 Novartis Gains European Approval for Its Innovative Flu Vaccine Optaflu
 
June 13
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 18
Letairis (ambrisentan) Tablets

Date of Approval: June 15, 2007

Company: Gilead Sciences, Inc.

Treatment for Pulmonary Hypertension

Letairis 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 18
Nuvigil (armodafinil) Tablets

Date of Approval: June 15, 2007

Company: Cephalon, Inc.

Treatment for Excessive Sleepiness

Nuvigil 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 18 FDA Approves New Orphan Drug Letairis for Treatment of Pulmonary Arterial Hypertension
 
June 19 The International Myeloma Foundation Says EMEA Marketing Approval of Revlimid is an Important Advance for Patients in Europe
 
June 20 FDA Approves Differin (adapalene) Gel, 0.3% for Acne
 
June 21
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 King Pharmaceuticals Announces FDA Approval of Epistaxis Kit for Thrombin-JMI
 
June 22
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
 
June 22 FDA Approves First Drug for Treating Fibromyalgia - Lyrica
 
June 22 Ranbaxy Receives Tentative Approval for Tamsulosin Capsules
 
June 22 FDA Approves Carnitor SF (Levocarnitine) Sugar-Free Oral Solution For Patients With Carnitine Deficiency
 
June 25 Genzyme Receives FDA Approval for New Labeling for Carticel
 
June 26 Allergan Announces FDA Approval of Label Extensions for Juvederm Ultra and Juvederm Ultra Plus
 

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