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New Drug Approvals Archive - October 2013

See also: New Indications and Dosage Forms for October 2013

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.

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.

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.

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.

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.

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.

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.

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.

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.

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