FDA approves ella tablets for prescription emergency contraception
The U.S. Food and Drug Administration today approved ella? (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.
ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Since May 2009, the prescription product has been available in Europe under the brand name ellaOne.
An FDA Advisory Committee for Reproductive Health Drugs discussed ella in June, 2010. The committee unanimously voted that the application for ella provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.
The safety and efficacy of ella were demonstrated in two Phase III clinical trials. One study was a prospective, multi-center, open-label, single-arm trial conducted in the United States; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland.
Side effects most frequently observed with ella in the clinical trials include: headache, nausea, abdominal pain, pain/discomfort during menstru
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance