New Drug Approvals Archive - September 2010

Lumigan (bimatoprost)

New Formulation Approved: August 31, 2010

• Allergan, Inc. Receives FDA Approval for Lumigan 0.01% as First-Line Therapy Indicated for the Reduction of Elevated Intraocular Pressure in Glaucoma Patients

Saphris (asenapine)

New Indication Approved: September 3, 2010

• Merck Receives Approval from FDA for Expanded Indications for Atypical Antipsychotic Medication Saphris (asenapine) Sublingual Tablets
• Saphris (asenapine) FDA Approval History

Faslodex (fulvestrant)

New Dosage Regimen: September 9, 2010

• FDA Approves New Dosing for Faslodex (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women

Protopam Chloride (pralidoxime chloride)

Patient Population Altered: September 8, 2010

• FDA Approves Pediatric Use of Protopam Chloride Chemical Poisoning Treatment

Krystexxa (pegloticase) Injection

Date of Approval: September 14, 2010
Company: Savient Pharmaceuticals, Inc.
Treatment for: Gout

Krystexxa (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.

• FDA Approves Krystexxa (pegloticase) for Gout
• Krystexxa (pegloticase) FDA Approval History

Gilenya (fingolimod) Capsules - formerly FTY720

Date of Approval: September 21, 2010
Company: Novartis
Treatment for: Multiple Sclerosis

Gilenya (fingolimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis.

• Novartis Gains FDA Approval For Gilenya, A Novel First-Line Multiple Sclerosis Treatment Shown To Significantly Reduce Relapses And Delay Disability Progression
• Gilenya (fingolimod) FDA Approval History

Ozurdex (dexamethasone)

New Indication Approved: September 24, 2010

• Allergan Receives FDA Approval for Ozurdex as Treatment Option for Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
• Ozurdex (dexamethasone) FDA Approval History

Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) Tablets

Date of Approval: September 24, 2010
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Contraception, Premenstrual Dysphoric Disorder, Acne

Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) is an estrogen/progestin combined oral contraceptive containing a folate, indicated for use by women to prevent pregnancy, treat symptoms of premenstrual dysphoric disorder, treat moderate acne and to raise folate levels in women who choose to use an oral contraceptive for contraception.

• FDA Approves Beyaz - Combination Contraceptive Containing a Folate
• Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) FDA Approval History

Kapvay (clonidine hydrochloride) Extended-Release Tablets

Date of Approval: September 28, 2010
Company: Shionogi Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Kapvay (clonidine hydrochloride) is a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

• Shionogi Announces FDA Approval of Kapvay - The First and Only Therapy Approved for Use with Stimulant Medication for the Treatment of ADHD
• Kapvay (clonidine hydrochloride) FDA Approval History

Gilenya (fingolimod)

Patient Population Altered: May 11, 2018

• FDA Expands Approval of Gilenya (fingolimod) to Treat Multiple Sclerosis in Pediatric Patients
• Gilenya (fingolimod) FDA Approval History