New Drug Approvals
The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.
See also: Generic Approvals, Approval Process, New Indications and Dosage forms
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Company: Novartis Pharmaceuticals Corporation
Date of Approval: August 26, 2010
Treatment for: Hypertension
Tekamlo (aliskiren and amlodipine) is a direct renin inhibitor and calcium channel blocker combination indicated for the treatment of high blood pressure.
- Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure - August 27, 2010
Company: HRA Pharma
Date of Approval: August 13, 2010
Treatment for: Postcoital Contraception
ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.
- FDA Approves ella Tablets for Prescription Emergency Contraception - August 16, 2010
- FDA Advisory Committee Unanimously Recommends Approval of HRA Pharma's Ulipristal Acetate for Emergency Contraception - June 18, 2010
Company: Braintree Laboratories, Inc.
Date of Approval: August 5, 2010
Treatment for: Bowel Preparation
Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
- FDA Approves Suprep Bowel Prep Kit - August 5, 2010
Company: Merz Pharmaceuticals, LLC
Date of Approval: July 30, 2010
Treatment for: Cervical Dystonia, Blepharospasm
Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of adults with cervical dystonia and blepharospasm.
- FDA Approves Merz Pharmaceuticals' Xeomin (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm - August 2, 2010
Company: Shionogi Pharma Inc.
Date of Approval: July 28, 2010
Treatment for: Chronic Drooling in Children
Cuvposa (glycopyrrolate) oral solution is an anticholinergic for the treatment of chronic severe drooling caused by neurologic disorders in children.
- FDA Approves Cuvposa for Chronic Drooling in Children - July 29, 2010
- Sciele Pharma Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric Patients - September 29, 2009
Company: Vistakon Pharmaceuticals LLC
Date of Approval: July 28, 2010
Treatment for: Allergic Conjunctivitis
Lastacaft (alcaftadine ophthalmic solution) is a topical H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.
- FDA Approves Lastacaft (alcaftadine ophthalmic solution) for Prevention of Itching Associated with Allergic Conjunctivitis - July 28, 2010
Company: Daiichi Sankyo, Inc.
Date of Approval: July 23, 2010
Treatment for: Hypertension
Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) is a three-in-one combination product taken once-daily for the treatment of hypertension.
- FDA Approves Tribenzor, A New Three-In-One Combination Product for the Treatment of High Blood Pressure - July 26, 2010
Company: Stiefel Laboratories, Inc.
Date of Approval: July 16, 2010
Treatment for: Acne
Veltin Gel (clindamycin phosphate and tretinoin) is a combination of an antibiotic and a retinoid indicated for the topical treatment of acne vulgaris.
- Stiefel, a GSK company, Receives FDA Approval of Veltin (clindamycin phosphate and tretinoin) Gel 1.2%/0.025% - July 16, 2010
- Connetics Receives FDA Non-Approvable Letter for Velac - June 13, 2005
- Connetics' New Drug Application for Velac Has Been Accepted for Filing by the FDA - October 25, 2004
Company: Strativa Pharmaceuticals
Date of Approval: July 2, 2010
Treatment for: Prevention of Chemotherapy-Induced, Radiotherapy-Induced, and Postoperative Nausea and Vomiting
Zuplenz is an oral soluble film formulation of ondansetron for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.
Zuplenz FDA Approval HistoryCompany: Kamada Ltd.
Date of Approval: July 1, 2010
Treatment for: Alpha-1 Proteinase Inhibitor Deficiency
Glassia is an alpha1-proteinase inhibitor that is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1antitrypsin deficiency.
- Kamada Wins FDA Approval for Glassia - a New Liquid, Ready-to-Use Treatment for Alpha-1 Antitrypsin Deficiency - July 6, 2010
- Kamada's Biologics License Application for IV-AAT to Treat Alpha-1 Antitrypsin Deficiency is Accepted for Review by the US Food and Drug Administration - August 4, 2009
- Kamada Submits U.S. Biologics License Application for the First Liquid, Ready to Use AAT for the Treatment of Alpha-1 Antitrypsin Deficiency - June 2, 2009
Company: Purdue Pharma L.P.
Date of Approval: June 30, 2010
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 - July 1, 2010
Company: King Pharmaceuticals, Inc.
Date of Approval: June 29, 2010
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 - July 7, 2010
Company: Merck & Co., Inc.
Date of Approval: June 22, 2010
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 - June 24, 2010
- Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma - July 23, 2009
Company: GlaxoSmithKline and Merck & Co., Inc.
Date of Approval: June 17, 2010
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) - June 18, 2010
Company: Sanofi-aventis
Date of Approval: June 17, 2010
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 FDA Approval HistoryCompany: GlaxoSmithKline
Date of Approval: June 14, 2010
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 - June 14, 2010
Company: Amgen Inc.
Date of Approval: June 1, 2010
Treatment for: Osteoporosis
Prolia is a RANK ligand (RANKL) inhibitor indicated for the treatment of postmenopausal women 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 - June 1, 2010
- Amgen Submits Denosumab Biologics License Application to FDA for the Reduction of Skeletal Related Events in Cancer Patients - May 17, 2010
- Amgen Provides Update on Status of Prolia (denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration (FDA) - October 21, 2009
- Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting - August 14, 2009
- FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab - February 18, 2009
- Amgen Submits Biologics License Application for FDA Approval of Denosumab in Women With Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation for Either Prostate or Breast Cancer - December 22, 2008
Company: Photocure ASA
Date of Approval: May 28, 2010
Treatment for: Diagnostic
Cysview (hexaminolevulinate HCl) is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder.
- Cysview (Hexaminolevulinate HCl) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer - June 2, 2010
- FDA has posted an Advisory Committee meeting with Photocure to discuss Hexvix NDA - November 23, 2009
- Photocure ASA (NO) - Hexvix has been granted priority review by the FDA - September 1, 2009
- Photocure submits application for marketing approval for Hexvix in USA to the FDA - July 1, 2009
- FDA Requests More Information Related to Hexvix NDA - April 20, 2006
Company: Genzyme Corporation
Date of Approval: May 24, 2010
Treatment for: Pompe disease
Lumizyme (alglucosidase alfa) is a lysosomal glycogen-specific enzyme indicated for patients 8 years and older with late (non-infantile) onset Pompe disease.
- FDA Approves Lumizyme for Late-Onset Pompe Disease - May 25, 2010
- Genzyme's Lumizyme BLA Receives Six-Month FDA Review - January 21, 2010
- Genzyme to Reopen Enrollment in Alglucosidase Alfa Temporary Access Program - December 7, 2009
- Genzyme Receives Complete Response Letter on Lumizyme Application - November 17, 2009
- Genzyme Submits All Information Requested by FDA for Lumizyme - May 21, 2009
- Genzyme Receives Complete Response Letter from FDA on Lumizyme Application - March 3, 2009
Company: Allergan, Inc.
Date of Approval: May 18, 2010
Treatment for: Bacterial Conjunctivitis
Zymaxid (gatifloxacin ophthalmic) is a fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Zymaxid FDA Approval HistoryFDA Drug Approvals Archive
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