The US Food and Drug Administration (FDA) on Wednesday revealed that it approved more than 700 abbreviated new drug applications (ANDAs) for generic drugs in 2016, though the number of ANDAs pending an industry response also rose by more than 700. According to the most recent generic drug review dashboard , the number of ANDAs filed with no communications yet from FDA also fell from 581 ANDAs as of 1 January 2016 to 351 ANDAs as of 1 January 2017. The dashboard s...

More approvals of new immune-checkpoint inhibitors, targeted and personalized therapies, as well as the use of real-world evidence are coming in the near future, Richard Pazdur, director of the Office of Hematology and Oncology at the US Food and Drug Administration (FDA) and associate director Gideon Blumenthal wrote in a comment published this week in Nature . Those expectations follow 2016 oncology approvals for FDA that included five new molecular entities and 17 ef...

China Food and Drug Administration (CFDA) is facing increasing pressure as a backlog of pharmaceutical marketing and clinical trial applications grow, though trial standards there are approaching those of international standards, according to a perspective published in Nature Reviews Clinical Oncology on Tuesday. At least part of the problem stems from the fact that CFDA uses “an overly strict approach” for approving clinical trial applications, which contrasts with a...

The US Food and Drug Administration (FDA) wasn't the only major regulator to OK fewer new drugs in 2016 than in recent years. Across the Atlantic, the European Medicines Agency (EMA) saw a similar decline in the number of drugs, with only 27 new active substances (NASs) recommended. In fact, both regulators saw the lowest number of new drugs given a positive review in their respective jurisdictions in years. For EMA, the number represents the fewest NASs recommended in a...

The US Food and Drug Administration (FDA) late Tuesday approved a generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) to help treat a sleep disorder but at least one investment analyst thinks the move could lead to a slippery slope of companies adding drug-drug interaction (DDI) patents and using them to keep generics from entering the market. In addition to granting approval to the generic, FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for ...

If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010. And with only 18 FDA decisions on new drugs expected in 2017, according to BioPharma Catalyst , the number of FDA approvals may continue to decline to a level the industry has not seen since 2007, when 18 new molecular entities (NMEs) and new biologic license applications (BLAs) were approved. But as John ...

The US Food and Drug Administration (FDA) on Tuesday announced a final rule amending regulations on citizen petitions that would ensure the agency does not delay the approval of a pending generic drug or biosimilar because of such petitions, unless that delay is necessary to protect the public health. The final rule, which is effective 9 January 2017, implements section 505(q) of the Federal Food, Drug & Cosmetics Act (FD&C Act), which governs the manner in which FDA ...

With less than half the number of new drugs approved in 2016 ( 19 so far ) when compared to 2015 (45 total ), John Jenkins, director of the US Food and Drug Administration’s (FDA) Office of New Drugs, told attendees Friday at a Prevision Policy conference in Washington, DC, that the decline has not been due to a shift in the agency’s standards or policies. “There are fewer applications in front of us to act upon,” Jenkins said, noting that although he cannot discuss in...

As the debate over skyrocketing drug prices continues, at least one solution has cropped up in nearly every conversation: Reduce the generic drug backlog at the US Food and Drug Administration (FDA), create more competition and drug prices will come down. But is the generic drug backlog, also known as the abbreviated new drug application (ANDA) backlog, that big of a problem? Or is confusion over what exactly this backlog means and how long it takes FDA to approve gener...

The US Food and Drug Administration (FDA) published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this month, revealing 651 approvals (though it’s 835 if tentative approvals are included), which was 159 more than the number of approvals for FY 2015 and 242 more than the agency approved in FY 2014 . But that high approval figure for last year also comes as the agency sent more complete response letters (CRLs) than any other year....

The US Food and Drug Administration (FDA) on Thursday announced that it has approved the first generic version of Roche’s Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older. Tamiflu, first approved in 1999, earned Roche more than $3 billion back in 2009 and more than $400 million in 2015, though its effectiveness was questioned back in 2014. Now, India-based Natco and ...

The common refrain that the US Food and Drug Administration (FDA) has been approving an exorbitantly high number of drug applications for generic drugs, known as abbreviated new drug applications (ANDAs), to increase market competition in recent years is slowing down in recent months. In the latest release of raw data on Tuesday of approvals and complete response letters (CRLs), also known as rejections, for ANDAs, FDA said that in the month ending 16 April 2016, it...