Ella, Morning After Pill Approved By FDAAug 14th, 2010 | By healthnews | Category: Health
A new morning after pill, also known as an emergency contraception pill, called Ella (ulipristal acetate) has been approved in tablet form by the US Food and Drug Administration (FDA). It has been approved as a prescription-only-product, and prevents pregnancy if taken within five days after unprotected sexual intercourse or contraceptive failure.
The FDA stresses that Ella is not intended for routine use as a contraceptive.
As a progesterone agonist/antagonist, Ella’s main likely effect is to inhibit or delay ovulation. It is known as EllaOne in Europe, where it has been on the market since May 2009, the FDA informs.
An FDA Advisory Committee for Reproductive Health Drugs met in June, 2010 to discuss the application for approval of the drug. The Committee voted unanimously for the drug’s approval after reviewing compelling data on efficacy and accepting that there was sufficient information on its safety.
Two Phase III clinical trials demonstrated the safety and efficacy of Ella. One was a prospective, multi-center, open-label, single-arm trial conducted in the USA; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the USA, UK and Ireland.
Possible side effects, reported from the clinical trials, include nausea, abdominal pain, headache, dysmenorrhea (menstrual cramps, period pains), and dizziness – similar to those found in other FDA-approved levonorgestrel emergency contraceptives.
The product label says that women with known or suspected pregnancy, as well as breastfeeding mothers should not use Ella.
The FDA adds that a patient package insert also will be provided to ensure that women are fully informed of the benefits and risks involved in the use of ella.
Ella is manufactured by Paris-based Laboratoire HRA Pharma. ella will be distributed by Watson Pharma Inc., of Morristown, N.J.
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