New Drug Approvals Archive - November 2010

Afinitor (everolimus)

New Indication Approved: October 29, 2010

• FDA Approves New Indication for Afinitor
• Afinitor (everolimus) FDA Approval History

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

Cymbalta (duloxetine)

New Indication Approved: November 4, 2010

• FDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain
• Cymbalta (duloxetine) FDA Approval History

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

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

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

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.

• FDA Approves Halaven for Late-Stage Breast Cancer
• Halaven (eribulin mesylate) FDA Approval History

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.

• 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

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

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

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

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

Xgeva (denosumab)

New Indication Approved: June 13, 2013

• FDA Approves Xgeva to Treat Giant Cell Tumor of the Bone
• Xgeva (denosumab) FDA Approval History

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

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

Xgeva (denosumab)

New Indication Approved: January 4, 2018

• FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma
• Xgeva (denosumab) FDA Approval History