New Drug Approvals Archive - September 2010
New Formulation Approved: August 31, 2010
New Indication Approved: September 3, 2010
New Dosage Regimen: September 9, 2010
Protopam Chloride (pralidoxime chloride)
Patient Population Altered: September 8, 2010
Krystexxa (pegloticase) Injection - formerly Puricase
Date of Approval: September 14, 2010
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
Gilenya (fingolimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis.
New Indication Approved: September 24, 2010
Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) Tablets
Date of Approval: September 24, 2010
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
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.