The FDA Approvals of 2010

The FDA approved 21 new drugs last year--fewer than both 2009 and 2008. Among these approvals six are biologics and 15 are small molecule drugs.
The FDA didn't break any new drug approval records in 2010. According to data provided by Bloomberg, only 21 new drugs got the green light last year--fewer than both 2009 and 2008, when 25 and 24 were approved, respectively. However, 2010 was better than 2007, when regulators set the all-time low mark of 18 approvals.
Six biologics and 15 small molecule drugs passed FDA inspection last year. And it doesn't seem as if there will be many banner years in the future, as the FDA gets tougher with safety data and places new warnings on existing drugs. Unlike 2009, when several companies brought multiple new drugs to the market, no drugmaker in 2010 had more than one new drug approved.
Source: fiercebiotech.com
Related News
-
News Panaxia's medical cannabis facility in Malta gains EU-GMP standard
This second facility gives the company a significant power multiplier for export capacity and geographical reach -
News CPHI Discover: Remote excipient audits are on the increase, but we must do more to develop novel excipients
Ahead of the session, Value Added Excipients to Unlock the Potential of APIs, at CPHI Discover on Thursday 18th May – global pharma’s largest ever virtual gathering – we spoke with one of the speakers, Dr Iain Moor... -
News Pharma Explained: What is Quality Risk Management & cGMPs?
Need clarity on determining your QA from your QbD and your cGMPs? You’re not alone! In our new Pharma Explained series from CPHI, we bring you clear cut definitions from industry experts on a myriad of Pharma Terms, delivered in bitesize video presenta... -
News Former FDA Commissioner lays out roadmap for building out excess capacity to deal with pandemic situations
Dr Scott Gottlieb shares insights into COVID-19 vaccine development, the upcoming US election and pharma pricing at the CPHI Festival of Pharma -
News Successful MHRA regulatory inspection for Scottish CMO Symbiosis
Inspection conducted remotely using video-conferencing and an online private document sharing platform. -
News Mylan and development partner win significant EPO ruling related to Copaxone
Decision clears legal pathway to expand access for patients living with multiple sclerosis in markets across Europe. -
News COVID-19 ushers in age of digital, flexible EU pharmaceutical regulation
The pandemic that has swept over the world in 2020 has caused huge disruption to the European pharmaceutical industry's regulatory procedures and supply chain management. But the crisis has also provided a platform for a learning process for the sy... -
News Europe's CHMP recommends suspension of medicines tested by Panexcell over flawed studies
The European Medicines Agency's human medicines committee (CHMP) has recommended the suspension of European marketing authorizations of generic medicines tested by Panexcell Clinical Laboratories at its site in Mumbai, India, citing irregularities in h...
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