Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

Report: FDA Approved 35 Drugs in FY 2011

By Pharmaceutical Processing | November 4, 2011

The FDA issued a report Thursday stating that the agency approved 35 new drugs in the 12 months ending September 30, marking the second highest number of approvals in the past decade, surpassed only by the 37 authorised in 2009. The approval rate is “a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients” FDA Commissioner Margaret Hamburg remarked.

 

The regulator attributed the authorisations to an expedited approval process, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act. The report comes as US Congress debates a renewal of the user-fee system already agreed upon by the FDA and the pharmaceutical industry, which would see a 6-percent fee increase through fiscal 2017. Under the deal, which Congress must approve by the end of September next year, drugmakers would pay $712.8 million in fees in fiscal 2013.

 

Janet Woodcock, director of the FDA’s center for drug evaluation and research, remarked that the regulator didn’t experience “a huge uptick” in the number of marketing applications in the 12-month period, but suggested that in previous years, many filings were for drugs that made moderate advances. “This year we’re just seeing a lot of innovation,” Woodcock commented. According to the FDA, almost half of the compounds cleared were considered “significant therapeutic advances over existing therapies” and 10 were for rare or orphan diseases.

 

The FDA noted that the report also demonstrated faster approval times in the US compared to other regulatory bodies. Specifically, 24 of the 35 approvals occurred in the US before any other country in the world and before the EU. Further, Richard Pazdur, leader of the office of oncology drug products within the center for drug evaluation and research, said approvals may accelerate as part of a September reorganisation of his office that focuses drug evaluation teams on afflicted body parts instead of the treatment’s composition.

 

Of the medications approved in the 12-month period, the FDA indicated that almost half were cleared under its priority review programme and three were authorised via the agency’s accelerated approval process. In addition, 34 of the 35 drugs were approved on or before review time targets and two-thirds were completed in a single review cycle. In terms of disease areas, the agency noted that seven of the new therapies provided “major advances in cancer treatment,” including Johnson & Johnson’s Zytiga (abiraterone) for metastatic prostate cancer and Roche and Daiichi Sankyo’s Zelboraf (vemurafenib) for metastatic melanoma. In addition, the regulator approved Seattle Genetics’ Adcetris (brentuximab vedotin), marking the first new drug for Hodgkin’s lymphoma in 30 years, and GlaxoSmithKline and Human Genome Sciences’ Benlysta (belimumab), which represents the first lupus treatment to garner approval in more than 55 years.

 

Related Articles Read More >

FDA logo
Ultra Supplement announces recall for undeclared tadalafil
analyzing medical sample
Expert answers to nitrosamine impurity questions
Cardinal Health
Cardinal Health announces $124M settlement of investors’ opioid suit
FDA logo
FDA warns four companies over selling honey tainted with prescription drugs

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards