New Drug Approvals Archive

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October 2013

October 3

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.

Duavee (bazedoxifene and conjugated estrogens) FDA Approval History

October 3

Clinolipid (lipid injectable emulsion)

Date of Approval: October 3, 2013
Treatment for: Parenteral Nutrition

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

Clinolipid (lipid injectable emulsion) FDA Approval History

October 8

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.

Adempas (riociguat) FDA Approval History

October 11

Nasacort (triamcinolone acetonide)

New Formulation Approved: October 11, 2013

October 11

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) FDA Approval History

October 15

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) FDA Approval History

October 18

Cimzia (certolizumab pegol)

New Indication Approved: October 17, 2013

Cimzia (certolizumab pegol) FDA Approval History

October 18

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.

Zorvolex (diclofenac) FDA Approval History

October 18

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.

Opsumit (macitentan) FDA Approval History

October 22

Actemra (tocilizumab)

New Formulation Approved: October 21, 2013

Actemra (tocilizumab) FDA Approval History

October 25

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.

Zohydro ER (hydrocodone) FDA Approval History

October 25

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.

Vizamyl (flutemetamol F 18) FDA Approval History

August 25

Zorvolex (diclofenac)

New Indication Approved: August 22, 2014

Zorvolex (diclofenac) FDA Approval History

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