New Drug Approvals Archive - June 2010

Prolia (denosumab) Injection

Date of Approval: June 1, 2010
Company: Amgen Inc.
Treatment for: Osteoporosis

Prolia is a RANK ligand (RANKL) inhibitor indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy, and to increase bone mass in men with osteoporosis at high risk for fracture.

• FDA Approves Amgen's Prolia (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture

Prolia (denosumab) FDA Approval History

Jalyn (dutasteride and tamsulosin) Capsules

Date of Approval: June 14, 2010
Company: GlaxoSmithKline
Treatment for: Benign Prostatic Hyperplasia

Jalyn is a combination of dutasteride (5α-reductase inhibitor) and tamsulosin (alpha-adrenergic antagonist) indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

• FDA approves Jalyn, a fixed-dose combination of dutasteride and tamsulosin, for symptomatic BPH in men with an enlarged prostate

Jalyn (dutasteride and tamsulosin) FDA Approval History

Jevtana (cabazitaxel) Injection

Date of Approval: June 17, 2010
Company: Sanofi-aventis
Treatment for: Prostate Cancer

Jevtana (cabazitaxel) is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with hormone-refractory metastatic prostate cancer.

• Jevtana (cabazitaxel) Injection Approved by U.S. FDA After Priority Review

Jevtana (cabazitaxel) FDA Approval History

Tasigna (nilotinib)

New Indication Approved: June 17, 2010

• Novartis International AG (CH) - FDA approves Tasigna for newly diagnosed chronic myeloid leukemia patients, data demonstrate major advance over Glivec

Tasigna (nilotinib) FDA Approval History

Staxyn (vardenafil) Orally Disintegrating Tablets

Date of Approval: June 17, 2010
Company: GlaxoSmithKline and Merck & Co., Inc.
Treatment for: Erectile Dysfunction

Staxyn (vardenafil) is a phosphodiesterase type 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.

• FDA approves Staxyn (vardenafil HCl) orally disintegrating tablets for erectile dysfunction (ED)

Staxyn (vardenafil) FDA Approval History

Namenda (memantine hydrochloride)

New Dosage Form Approved: June 21, 2010

• Forest and Merz Announce FDA Approval of Namenda XR for the Treatment of Moderate to Severe Dementia of the Alzheimer's Type

Lucentis (ranibizumab)

New Indication Approved: June 22, 2010
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

• FDA Approves Lucentis (ranibizumab) for the Treatment of Macular Edema Following Retinal Vein Occlusion

Lucentis (ranibizumab) FDA Approval History

Dulera (mometasone furoate and formoterol fumarate) Inhaler

Date of Approval: June 22, 2010
Company: Merck & Co., Inc.
Treatment for: Asthma

Dulera (mometasone furoate and formoterol fumarate) is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for the treatment of asthma in patients 12 years of age and older.

• FDA Approves Merck's Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol for the Treatment of Asthma in Patients 12 Years of Age and Older

Dulera (mometasone furoate and formoterol fumarate) FDA Approval History

Butrans (buprenorphine) Transdermal System

Date of Approval: June 30, 2010
Company: Purdue Pharma L.P.
Treatment for: Pain

Butrans (buprenorphine) is a transdermal opioid analgesic for the management of moderate to severe chronic pain in patients requiring continuous treatment for an extended period of time.

• Purdue Pharma L.P. Receives FDA Approval for Butrans (buprenorphine) Transdermal System CIII

Butrans (buprenorphine) FDA Approval History

Alsuma (sumatriptan) Injection

Date of Approval: June 29, 2010
Company: King Pharmaceuticals, Inc.
Treatment for: Migraine, Cluster Headache

Alsuma (sumatriptan injection) is a triptan indicated for the acute treatment of migraine attacks and cluster headache episodes.

• FDA Approves Alsuma Auto-Injector

Alsuma (sumatriptan) FDA Approval History

Prolia (denosumab)

New Indication Approved: September 16, 2011

• FDA Approves New Indications for Prolia (denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy

Prolia (denosumab) FDA Approval History

Prolia (denosumab)

New Indication Approved: September 21, 2012

• FDA Approves New Indication For Prolia (Denosumab) For The Treatment Of Bone Loss In Men With Osteoporosis At High Risk For Fracture

Prolia (denosumab) FDA Approval History

Butrans (buprenorphine)

New Dosage Regimen: September 24, 2013

• Purdue Pharma L.P. Receives FDA Approval For 15 mcg/hour Dosage Strength Of Butrans (buprenorphine) Transdermal System CIII

Butrans (buprenorphine) FDA Approval History