New Drugs Approved Summer 2010

New drugs not only offer hope, but possibly a better quality of life, for many waiting for 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

Source: Julie Bohlen, MBA-HCM, ELS

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