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 |
||
|
ella (aliskiren and amiodipine) |
August 13 |
Postcoital Contraception – emergency contraception |
|
|
Suprep (sodium sulfate, potassium sulfate, magnesium |
August |
Bowel Preparation – cleansing colon prior to colonoscopy |
|
|
Xeomin (incobotulinumtoxinA) |
July |
||
|
Cuvposa (glycopyrrolate) Oral Solution |
July |
Chronic Drooling in Children |
|
|
Lastacaft (alcaftadine) Ophthalmic |
July |
|
Allergic Conjunctivitis – itchy eyes associated with eye allergies |
|
Tribenzor (amlodipine, hydrochlorothiazide |
July |
Hypertension |
|
|
Veltin (clindamycin and tretinoin) Gel – formerly Velac |
July |
Acne |
|
|
Zuplenz (ondansetron) Oral
|
July |
|
Prevention |
|
Glassia (alpha1-proteinase inhibitor Injection) – formerly |
July |
|
Alpha-1 |
|
Butrans (buprenorphine) Transdermal System |
June |
Pain |
|
|
Alsuma (sumatriptan) Injection |
June |
||
|
Dulera (mometasone furoate and formoterol fumarate) Inhaler |
June |
|
Asthma |
|
Staxyn (vardenafil) Orally |
June |
GlaxoSmithKline |
|
|
Jevtana (cabazitaxel) Injection
|
June |
|
Prostate Cancer – in combination with prednisone for hormone-refractory metastatic |
|
Jalyn (dutasteride and tamsulosin) Capsules |
June |
|
Benign |
|
Prolia (denosumab) Injection |
June |
Osteoporosis |
(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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