New Drug Approvals Archive - October 2013

Duavee (bazedoxifene and conjugated estrogens) Tablets

Date of Approval: October 3, 2013
Company: Pfizer Inc.
Treatment for: Postmenopausal Symptoms, Prevention of Osteoporosis

Duavee (bazedoxifene and conjugated estrogens) is an estrogen agonist/antagonist and conjugated estrogens combination indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause, and prevention of postmenopausal osteoporosis in women with an intact uterus.

• FDA Approves Duavee to Treat Hot Flashes and Prevent Osteoporosis

Duavee (bazedoxifene and conjugated estrogens) FDA Approval History

Clinolipid (lipid injectable emulsion)

Date of Approval: October 3, 2013
Company: Baxter Healthcare Corporation
Treatment for: Parenteral Nutrition

Clinolipid (lipid injectable emulsion) is an intravenous fat supplement indicated for parenteral nutrition.

• FDA Approves Clinolipid for Intravenous Nutrition

Clinolipid (lipid injectable emulsion) FDA Approval History

Adempas (riociguat) Tablets

Date of Approval: October 8, 2013
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Pulmonary Hypertension

Adempas (riociguat) is an oral soluble guanylate cyclase (sGC) stimulator for the treatment of pulmonary hypertension.

• FDA Approves Adempas to Treat Pulmonary Hypertension

Adempas (riociguat) FDA Approval History

Nasacort (triamcinolone acetonide)

New Formulation Approved: October 11, 2013

• FDA Approves Sanofi's Nasacort Allergy 24HR for Over-the-Counter Use

Otrexup (methotrexate) Subcutaneous Injection

Date of Approval: October 11, 2013
Company: Antares Pharma, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriasis

Otrexup (methotrexate) is a folate analog metabolic inhibitor self-administered once weekly for use in the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriasis.

• Otrexup (Methotrexate) Injection Approved By FDA

Otrexup (methotrexate) FDA Approval History

Novoeight (turoctocog alfa) for Intravenous Injection

Date of Approval: October 15, 2013
Company: Novo Nordisk
Treatment for: Hemophilia A

Novoeight (turoctocog alfa) is an antihemophilic factor (recombinant) indicated for use in adults and children with hemophilia A.

• NovoEight (turoctocog alfa) Receives Approval from the FDA

Novoeight (turoctocog alfa) FDA Approval History

Cimzia (certolizumab pegol)

New Indication Approved: October 17, 2013

• Cimzia Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis

Cimzia (certolizumab pegol) FDA Approval History

Zorvolex (diclofenac) Capsules

Date of Approval: October 18, 2013
Company: Iroko Pharmaceuticals, LLC
Treatment for: Pain, Osteoarthritis

Zorvolex (diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain, and for the management of osteoarthritis pain.

• Iroko Pharmaceuticals Receives FDA Approval for Zorvolex

Zorvolex (diclofenac) FDA Approval History

Opsumit (macitentan) Tablets

Date of Approval: October 18, 2013
Company: Actelion Pharmaceuticals Ltd.
Treatment for: Pulmonary Hypertension

Opsumit (macitentan) is a dual endothelin receptor antagonist for the treatment of patients with pulmonary arterial hypertension.

• FDA Approves Opsumit to Treat Pulmonary Arterial Hypertension

Opsumit (macitentan) FDA Approval History

Actemra (tocilizumab)

New Formulation Approved: October 21, 2013

• Genentech Gains FDA Approval for New Subcutaneous Formulation of Actemra for use in Adult Patients Living with Moderately to Severely Active Rheumatoid Arthritis

Actemra (tocilizumab) FDA Approval History

Zohydro ER (hydrocodone) Extended-Release Capsules

Date of Approval: October 25, 2013
Company: Zogenix, Inc.
Treatment for: Pain

Zohydro ER (hydrocodone) is a single-entity (without acetaminophen) extended-release opioid analgesic for around-the-clock management of moderate to severe chronic pain.

• FDA Approves Zohydro ER, an Extended-Release, Single-Entity Hydrocodone Product

Zohydro ER (hydrocodone) FDA Approval History

Vizamyl (flutemetamol F 18) Injection

Date of Approval: October 25, 2013
Company: GE Healthcare
Treatment for: Diagnostic

Vizamyl (flutemetamol F 18) is a PET amyloid imaging agent for the evaluation of Alzheimer's disease or other cognitive disorders.

• FDA Approves Vizamyl Brain Imaging Drug to Help Evaluate Patients for Alzheimer’s Disease, Dementia

Vizamyl (flutemetamol F 18) FDA Approval History

Zorvolex (diclofenac)

New Indication Approved: August 22, 2014

• Iroko Pharmaceuticals Gains FDA Approval of Zorvolex for Management of Osteoarthritis Pain

Zorvolex (diclofenac) FDA Approval History

Zohydro ER (hydrocodone)

New Formulation Approved: January 30, 2015

• Zogenix Receives FDA Approval for New Abuse-Deterrent Formulation of Zohydro ER

Zohydro ER (hydrocodone) FDA Approval History