US agency approves 'five-day-after' contraceptive pill

Aug 14, 2010

A US regulatory agency on Friday approved an emergency contraceptive pill that can prevent pregnancy if taken up to five days after unprotected sex.

The Food and Administration said it granted approval for the drug, called ella, after two phase III clinical trials that "provided compelling data on efficacy and sufficient information on safety."

The drug, manufactured by French firm HRA Pharma, successfully "prevents pregnancy when taken orally within 120 hours (five days) after a failure or unprotected intercourse," the FDA said in a statement.

"It is not intended for routine use as a contraceptive," the agency added.

The drug works by inhibiting or delaying ovulation, and has side effects similar to other emergency contraceptives already on the market, such as Plan B, which prevents if taken within 72 hours after intercourse.

The drug's approval followed a positive recommendation by an FDA advisory committee on June 17.

The drug has been available in Europe since May 2009, under the name ellaOne, and will be distributed into the United States by New Jersey-based Watson Pharma Inc.

Explore further: FDA approves second vaccine against meningitis strain

add to favorites email to friend print save as pdf

Related Stories

FDA panel to consider new 'morning-after pill'

Jun 08, 2010

A Food and Drug Administration advisory committee will meet June 17 to consider whether the agency should approve a new emergency contraceptive that studies show is more effective than Plan B, the only "morning-after pill" ...

'Morning After Pill' Works up to 5 Days After Sex

Feb 22, 2010

(PhysOrg.com) -- A team of researchers from the United States and Europe has published new evidence supporting the use of ulipristal acetate as an effective alternative to levonorgestrel (marketed as Plan B®) for emergency ...

New morning-after pill works for up to 5 days

Jan 29, 2010

(AP) -- A new type of morning-after pill is more effective than the most widely used drug at preventing pregnancies in women who had unprotected sex and also works longer, for up to five days, a new study says.

FDA OKs morning-after pill retail sale

Aug 24, 2006

Over-the-counter sale of Plan B, or the morning-after contraceptive pill was approved by the U.S. Food and Drug Administration Thursday.

New 5-Day 'Morning-After' Pill Tested For U.S. Approval

Jan 22, 2010

(PhysOrg.com) -- Currently, women who seek emergency contraception within 72 hours of intercourse can receive copper intrauterine devices. Though the devices are very effective at preventing pregnancy, they ...

Recommended for you

Medical charity warns India over patent rules

Jan 21, 2015

Doctors without Borders on Wednesday warned the Indian government not to bow to US pressure to amend patent regulations that allow millions access to affordable medicines, ahead of a visit by President Barack Obama.

Why are some generic drugs getting so expensive?

Jan 21, 2015

More than eight out of every 10 prescriptions dispensed in the US is generic. This growth is due to a large number of top-selling drugs going off patent over the past decade, as well as innovations in t ...

Supreme Court sides with Teva in drug dispute

Jan 20, 2015

The Supreme Court on Tuesday sided with Teva Pharmaceutical Industries Ltd. in the company's high-profile patent dispute with rival firms over the top-selling multiple sclerosis drug.

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.