New Drug Approvals Archive - November 2010
See also: New Indications and Dosage Forms for November 2010
November 2010
Ofirmev (acetaminophen) Intravenous Injection - formerly Acetavance
Date of Approval: November 2, 2010
Company: Cadence Pharmaceuticals, Inc.
Treatment for: Pain, Fever
Ofirmev (acetaminophen) is an intravenous analgesic product for the treatment of acute pain and fever in adults and children.
Kombiglyze XR (saxagliptin and metformin) Extended-Release Tablets
Date of Approval: November 5, 2010
Company: AstraZeneca
Treatment for: Diabetes, Type 2
Kombiglyze XR (saxagliptin and metformin) is a once-daily fixed dose combination of the dipeptidyl peptidase-4 (DPP-4) inhibitor Onglyza (saxagliptin) and extended release metformin for the treatment of type 2 diabetes.
Egrifta (tesamorelin) Injection
Date of Approval: November 10, 2010
Company: Theratechnologies
Treatment for: Reduction of Excess Abdominal Fat in HIV-Infected Patients with Lipodystrophy
Egrifta (tesamorelin) is a synthetic analogue of growth hormone releasing factor (GRF) for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
Halaven (eribulin mesylate) Injection
Date of Approval: November 15, 2010
Company: Eisai Co., Ltd.
Halaven (eribulin mesylate) is a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer, and liposarcoma.
Xgeva (denosumab) Injection
Date of Approval: November 18, 2010
Company: Amgen Inc.
Treatment for: Osteolytic Bone Metastases of Solid Tumors, Osteolytic Bone Lesions of Multiple Myeloma, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy
Xgeva (denosumab) is a RANK ligand (RANKL) inhibitor indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Xgeva is also indicated for treatment giant cell tumor of bone and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Moxeza (moxifloxacin) Ophthalmic Solution
Date of Approval: November 19, 2010
Company: Alcon, Inc.
Treatment for: Conjunctivitis, Bacterial
Moxeza (moxifloxacin hydrochloride ophthalmic solution) is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Gablofen (baclofen) Injection
Date of Approval: November 19, 2010
Company: CNS Therapeutics
Treatment for: Cerebral Spasticity, Chronic Spasticity
Gablofen (baclofen) is a gamma-aminobutyric acid (GABA) ergic agonist indicated for use in the management of severe spasticity.
Axiron (testosterone) Topical Solution
Date of Approval: November 23, 2010
Company: Eli Lilly and Company
Treatment for: Hypogonadism, Male
Marketing Status: Discontinued
Axiron (testosterone) is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
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