New Drugs Approved Summer 2010

New drugs not only offer hope, but possibly a better quality of life, for those awaiting new treatments. However, new drug approvals can also spark controversy. The FDA approved 17 new drugs this summer (June-August 2010). Many offer new promise, and one in particular promises a great deal of future debate.

Since nearly one in three Americans has high blood pressure, it isn't surprising that two of the 17 newly approved drugs are antihypertensives. The most recently approved drug is Tekamlo (aliskiren and amlodipine) from Novartis, a single-pill combination drug for high blood pressure. Tribenzor is a new three-in-one combination drug that is taken once-daily to treat high blood pressure.  

The most controversial newly approved drug is the emergency contraceptive ella (ulipristal acetate) that can prevent pregancy for up to 5 days after sex.  Plan B, the so-called morning after pill, is less effective and can only be used within 3 days of having sex. ella has been available as ellaOne in Europe since May 2009 and will be available to US women this fall.

Many are against the FDA approval of ella as a contraceptive when it can be used to induce abortion. Representative Chris Smith (R-NJ) says this classification may pave the way to “covertly allow federal funding for abortion." (1)  Supporters and opponents agree this approval highlights the increasing influence of the FDA on political ideology and will be entangled with future political and regulatory battles.

A promising new drug, Cuvposa (glypopyrrolate), is the first liquid treatment for children who suffer from chronic severe drooling associated with neurologic conditions such as cerebral palsy. The FDA reports that 78% of children on this drug reached clinical improvement during trials. 

The 17 new drugs approved this summer with their indications are listed in Figure 1. New drugs for asthma (Dulera), enlarged prostate (Jalyn), migraine (Alsuma), osteoporosis (Prolia), acne (Veltin), and erectile dysfunction (Staxyn) are a sampling of 2010 FDA approvals.  

Figure 1: FDA Newly Approved Drugs Summer 2010 (June-August) 

Drug	Approval 2010	Company	Indication
Tekamlo (aliskiren and amlodipine)	August 26	Novartis Pharmaceuticals	Hypertension
ella (aliskiren and amiodipine)	August 13	HRA Pharma	Postcoital Contraception - emergency contraception
Suprep (sodium sulfate, potassium sulfate, magnesium sulfate)  - Oral	August 5	Braintree Laboratories	Bowel Preparation – cleansing colon prior to colonoscopy
Xeomin (incobotulinumtoxinA)	July 30	Merz Pharmaceuticals	Cervical Dystonia, Blepharospasm
Cuvposa (glycopyrrolate) Oral Solution	July 28	Shionogi Pharma, Inc	Chronic Drooling in Children
Lastacaft (alcaftadine) Ophthalmic Solution	July 28	Vistakon Pharmaceuticals	Allergic Conjunctivitis - itchy eyes associated with eye allergies
Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) Tabs	July 23	Daiichi Sankyo, Inc.	Hypertension – once-daily treatment
Veltin (clindamycin and tretinoin) Gel - formerly Velac	July 16	Stiefel Laboratories, Inc.	Acne - antibiotic and retinoid for topical treatment of acne
Zuplenz (ondansetron) Oral Soluble Film	July 2	Strativa Pharmaceuticals	Prevention of Chemotherapy-Induced, Radiotherapy-Induced, and Postoperative Nausea and Vomiting
Glassia (alpha1-proteinase inhibitor Injection) - formerly AAT-IV	July 1	Kamada Ltd.	Alpha-1 Proteinase Inhibitor Deficiency – in adults with emphysema
Butrans (buprenorphine) Transdermal System	June 30	Purdue Pharma L.P.	Pain – management of moderate to severe chronic pain
Alsuma (sumatriptan) Injection	June 29	King Pharmaceuticals	Migraine, Cluster Headache
Dulera (mometasone furoate and formoterol fumarate) Inhaler	June 22	Merck & Co.	Asthma – in people 12 years of age and older
Staxyn (vardenafil) Orally Disintegrating Tablets	June 17	GlaxoSmithKline and Merck & Co.	Erectile Dysfunction
Jevtana (cabazitaxel) Injection	June 17	Sanofi-Aventis	Prostate Cancer - in combination with prednisone for hormone-refractory metastatic prostate cancer
Jalyn (dutasteride and tamsulosin) Capsules	June 14	GlaxoSmithKline	Benign Prostatic Hyperplasia – in men with enlarged prostate
Prolia (denosumab) Injection	June 1	Amgen Inc.	Osteoporosis – in women at high risk for fracture

      (1). Stein, Rob. FDA approves ella as a 5-day-after emergency contraceptive. The Washington Post. August 14, 2010. 

Past blog entries on trending health topics on OrganizedWisdom or popular health searches on the Web:

Popular Celebrity Cancer Searches for August 2010 
10 Healthiest Foods 
10 Trending Health Topics...Hot Off the Press 
5 Trending Health Topics: Health Questions You're Too Afraid to Ask 
10 Trending Health Searches: Crisis-Everywhere-You-Turn Edition (April 26-May 2) 
5 Trending Health Topics: Healthy Skin Edition

By Julie Bohlen, MBA/HCM, ELS

http://www.blogcatalog.com/directory/lifestyle/health/

 

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