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New Drug Approvals Archive - September 2010

See also: New Indications and Dosage Forms for September 2010

September 2010

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.

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.

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.

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.

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