New Drug Approvals Archive

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November 2010

November 1

Afinitor (everolimus)

New Indication Approved: October 29, 2010

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: Fever, Pain

Ofirmev (acetaminophen) is an intravenous analgesic product for the treatment of acute pain and fever in adults and children.

Ofirmev (acetaminophen) FDA Approval History

November 5

Cymbalta (duloxetine)

New Indication Approved: November 4, 2010

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) 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.

Egrifta (tesamorelin) FDA Approval History

November 15

Vyvanse (lisdexamfetamine dimesylate)

Patient Population Altered: November 10, 2010

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

November 15

Halaven (eribulin mesylate) Injection - formerly E7389

Date of Approval: November 15, 2010
Company: Eisai Co., Ltd.
Treatment for: Breast Cancer

Halaven (eribulin mesylate) is a microtubule inhibitor indicated for the treatment of patients with metastatic 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.

Xgeva (denosumab) FDA Approval History

November 19

Nexterone (amiodarone HCl)

New Formulation Approved: November 16, 2010

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.

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.

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.

Axiron (testosterone) FDA Approval History

June 13

Xgeva (denosumab)

New Indication Approved: June 13, 2013

Xgeva (denosumab) FDA Approval History

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