New Drug Approvals Archive

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September 2010

September 1

Lumigan (bimatoprost)

New Formulation Approved: August 31, 2010

September 7

Saphris (asenapine)

New Indication Approved: September 3, 2010

Saphris (asenapine) FDA Approval History

September 13

Faslodex (fulvestrant)

New Dosage Regimen: September 9, 2010

September 13

Protopam Chloride (pralidoxime chloride)

Patient Population Altered: September 8, 2010

September 14

Krystexxa (pegloticase) Injection - formerly Puricase

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.

Krystexxa (pegloticase) FDA Approval History

September 21

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.

Gilenya (fingolimod) FDA Approval History

September 25

Ozurdex (dexamethasone)

New Indication Approved: September 24, 2010

Ozurdex (dexamethasone) FDA Approval History

September 24

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.

Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) FDA Approval History

September 28

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.

Kapvay (clonidine hydrochloride) FDA Approval History

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