AstraZeneca Remains Confident in the NDA Submission for Ticagrelor
AstraZeneca says it remains confident in the NDA submission for ticagrelor and will continue to work with the FDA to progress towards the completion of the review.
AstraZeneca announced that it has replied to the US FDA Complete Response Letter (CRL) received for the ticagrelor New Drug Application on 16 December 2010.
The additional analyses of the PLATO trial requested in the CRL focused primarily on interactions between ticagrelor and high dose aspirin. AstraZeneca believes these supplementary analyses support the hypothesis that the apparent difference in treatment effect observed in the US and non-US patient subsets in PLATO is most likely a reflection of an underlying interaction between ticagrelor and higher doses of aspirin.
AstraZeneca remains of the view that either the play of chance or an interaction
Related News
-
News CPHI Milan 2024 - From the Floor
Milan and CPHI welcome you to 2024 CPHI Milan! As we celebrate the 35th edition of our flagship CPHI show, editors Vivian Xie and Lucy Chard bring you the latest from the show floor, conference sessions, and innovative solutions from all exhibitors, at... -
News The BIOSECURE Act: implications for the pharma supply chain
On September 9, 2024, the US House of Representatives voted to pass the bill titled the BIOSECURE Act (the Act), which lists several Chinese companies in the pharmaceutical supply chain. The Act will prohibit American companies from contracting or doin... -
News A Day in the Life of a Global CDMO Chapter Lead – Manufacturing
The 'Day in the Life of' series has covered many aspects of the pharmaceutical pipeline, including R&D and procurement, now we're taking a look at manufacturing from a global CDMO perspective. -
News CPHI Milan Speaker Spotlight: CDMO relations with Pharma and Start-Ups
In the run-up to CPHI Milan, we sit down with some of the experts and thought-leaders speaking at this year’s conferences. -
.png)
News Women in Pharma: Advocating for trans healthcare in pharma
In our monthly series on women in the pharmaceutical industry, we interview leading experts in the pharmaceutical supply and value chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News Updated – Changing abortion pill access according to the US FDA and Supreme Court
After the approval of the medical abortion pill, mifepristone, by the US FDA, states across the USA approach the distribution of the pill differently, some ruling against allowing access to the drug. -
News CPHI North America 2024 – From the Floor
Welcome to Philly! CPHI North America once again graces the Philadelphia Convention Center, 7–9 May 2024. -
.png)
News Drug Patent Expiries: a steep cliff or opportunity for innovation?
The pharmaceutical industry faces a patent cliff together in the years leading up to 2030. Learn what this means for drug pricing, their outsourcing partners, and drug innovation of the future.
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