New Drug Approvals Archive - 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.

Cadence Pharmaceuticals Announces FDA Approval of Ofirmev (acetaminophen) injection for the Management of Pain and Fever
Ofirmev (acetaminophen) 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.

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: Bacterial Conjunctivitis

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

Axiron (testosterone) is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.