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New Drug Approvals Archive

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June 2007

June 1

Norditropin (somatropin [rDNA origin])

New Indication Approved: May 31, 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.

Divigel (estradiol) FDA Approval History

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.

Extina (ketoconazole) FDA Approval History

June 15

Apidra (insulin glulisine)

New Dosage Regimen: April 12, 2007

Apidra (insulin glulisine) FDA Approval History

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.

Letairis (ambrisentan) FDA Approval History

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).

Nuvigil (armodafinil) FDA Approval History

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 (amlodipine and valsartan) FDA Approval History

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.

Endometrin (progesterone) FDA Approval History

June 22

Lyrica (pregabalin)

New Indication Approved: June 21, 2007

Lyrica (pregabalin) FDA Approval History

August 4

Exforge (amlodipine and valsartan)

New Indication Approved: July 23, 2008

Exforge (amlodipine and valsartan) FDA Approval History

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