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New Drug Approvals Archive - November 2010

November 2010

November 1	Afinitor (everolimus) New Indication Approved: October 29, 2010 FDA Approves New Indication for Afinitor Afinitor (everolimus) FDA Approval History
November 2	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. Cadence Pharmaceuticals Announces FDA Approval of Ofirmev (acetaminophen) injection for the Management of Pain and Fever Ofirmev (acetaminophen) FDA Approval History
November 5	Cymbalta (duloxetine) New Indication Approved: November 4, 2010 FDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain Cymbalta (duloxetine) FDA Approval History
November 5	Kombiglyze XR (saxagliptin and metformin) Extended-Release Tablets Date of Approval: November 5, 2010 Company: Bristol-Myers Squibb Company and 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. Kombiglyze XR (Saxagliptin and Metformin HCl Extended-Release) Tablets Approved in the U.S. for the Treatment of Type 2 Diabetes Mellitus in Adults Kombiglyze XR (saxagliptin and metformin) FDA Approval History
November 10	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. FDA Approves Egrifta (tesamorelin for injection): First and Only Treatment for the Reduction of Excess Abdominal Fat in HIV-infected Patients with Lipodystrophy Egrifta (tesamorelin) FDA Approval History
November 15	Vyvanse (lisdexamfetamine dimesylate) Patient Population Altered: November 10, 2010 FDA Approves Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents Vyvanse (lisdexamfetamine dimesylate) FDA Approval History
November 15	Halaven (eribulin mesylate) Injection - formerly E7389 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. FDA Approves Halaven for Late-Stage Breast Cancer Halaven (eribulin mesylate) FDA Approval History
November 18	Xgeva (denosumab) Injection Date of Approval: November 18, 2010 Company: Amgen Inc. Treatment for: Osteolytic Bone Metastases of Solid Tumors, Neoplasm of Bone Xgeva (denosumab) is a RANK ligand (RANKL) inhibitor indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, and for the treatment of giant cell tumor of the bone. FDA Approves Amgen's Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors Xgeva (denosumab) FDA Approval History
November 19	Nexterone (amiodarone HCl) New Formulation Approved: November 16, 2010 Prism Pharmaceuticals Receives FDA Approval of Ready-to-Use Nexterone (Amiodarone HCl) Premixed Injection Nexterone (amiodarone HCl) FDA Approval History
November 19	Moxeza (moxifloxacin) Ophthalmic Solution Date of Approval: November 19, 2010 Company: Alcon, Inc. Treatment for: Bacterial Conjunctivitis Moxeza (moxifloxacin hydrochloride ophthalmic solution) is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. FDA Approves Moxeza for Bacterial Conjunctivitis Moxeza (moxifloxacin) FDA Approval History
November 19	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. FDA Approves Movement Disorder Drug from CNS Therapeutics: Gablofen (Baclofen Injection) for the Treatment of Severe Spasticity Gablofen (baclofen) FDA Approval History
November 23	Axiron (testosterone) Topical Solution Date of Approval: November 23, 2010 Company: Eli Lilly and Company Treatment for: Hypogonadism -- Male Axiron (testosterone) is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Lilly and Acrux Receive FDA Approval for Axiron (Testosterone) Topical Solution CIII Axiron (testosterone) FDA Approval History
June 13	Xgeva (denosumab) New Indication Approved: June 13, 2013 FDA Approves Xgeva to Treat Giant Cell Tumor of the Bone Xgeva (denosumab) FDA Approval History
December 8	Xgeva (denosumab) New Indication Approved: December 5, 2014 FDA Approves Xgeva (denosumab) for Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy Xgeva (denosumab) FDA Approval History
January 28	Halaven (eribulin mesylate) New Indication Approved: January 28, 2016 FDA Approves Halaven (eribulin mesylate) for the Treatment of Liposarcoma Halaven (eribulin mesylate) FDA Approval History

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