New Drug Approvals Archive - September 2010
New Formulation Approved: August 31, 2010
New Indication Approved: September 3, 2010
- Merck Receives Approval from FDA for Expanded Indications for Atypical Antipsychotic Medication Saphris (asenapine) Sublingual Tablets
Read more: Saphris (asenapine) FDA Approval History
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
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.
Read more: Krystexxa (pegloticase) FDA Approval History
Gilenya (fingolimod) Capsules - formerly FTY720
Date of Approval: September 21, 2010
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
Read more: Gilenya (fingolimod) FDA Approval History
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
Read more: 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.
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