Drugs

948 ANDAs Approved in 2020

The 2020 annual report of the CDER Office of Generic Drugs shows that 948 ANDAs -- 223 or 19% fewer than in 2019 -- were approved or tentatively approved in 2020, including 72 first generic drugs. The report also shows that 187 product-specific guidances were issued for industry and other stakeholders, including 93 new drafts and 92 revised drafts. The total number of product-specific guidances now available for use is 1,865.

OGD director Sally Choe says that in response to the Covid-19 pandemic, more than 660 supplements and 50 original applications were approved for drug products used to treat Covid-19 patients. Also, she says, OGD identified and pursued tools and strategies to aid in the fight against Covid-19. It created a system for identifying generic drugs that are critical to treating patients with Covid-19 and subsequently took regulatory and scientific actions to accelerate the review of those products. Choe writes that the system included establishing the infrastructure to rapidly complete tasks and resolve review issues to support taking timely actions on critical generic drugs used in the pandemic.

According to Choe, an important tool used to communicate with prospective generic drug applicants is called controlled correspondence — a request submitted to FDA for information on a specific element of generic drug product development. She writes that in 2020 FDA responded to a record 3,711 controlled correspondence inquiries submitted by industry.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome