New Drug Approvals Archive

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June 2010

June 1

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.

Prolia (denosumab) FDA Approval History

June 14

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.

Jalyn (dutasteride and tamsulosin) FDA Approval History

June 17

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) FDA Approval History

June 18

Tasigna (nilotinib)

New Indication Approved: June 17, 2010

Tasigna (nilotinib) FDA Approval History

June 17

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.

Staxyn (vardenafil) FDA Approval History

June 22

Namenda (memantine hydrochloride)

New Dosage Form Approved: June 21, 2010

June 23

Lucentis (ranibizumab)

New Indication Approved: June 22, 2010

Lucentis (ranibizumab) FDA Approval History

June 22

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.

Dulera (mometasone furoate and formoterol fumarate) FDA Approval History

June 30

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.

Butrans (buprenorphine) FDA Approval History

June 29

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.

Alsuma (sumatriptan) FDA Approval History

September 19

Prolia (denosumab)

New Indication Approved: September 16, 2011

Prolia (denosumab) FDA Approval History

September 21

Prolia (denosumab)

New Indication Approved: September 21, 2012

Prolia (denosumab) FDA Approval History

September 24

Butrans (buprenorphine)

New Dosage Regimen: September 24, 2013

Butrans (buprenorphine) FDA Approval History

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