Drugs

Nearly 1,000 Generic Drugs OKd in 2023

The CDER Office of Generic Drugs (OGD) approved or tentatively approved 956 generic drug applications in 2023. The OGD 2023 Annual Report says there were 90 first generic medicines approved. It notes that first generics “provide access where no generic competition previously existed [and] because of their importance to public health, FDA prioritizes review of submissions for these products.”

The report says OGD communicated with industry through 4,074 information requests, 2,333 discipline review letters, and 1,490 complete response letters. “These requests and letters identify issues that need to be addressed by applicants before FDA can approve an application,” it says.

In 2023, OGP received 3,555 controlled correspondence inquiries, which are inquiries submitted by or on behalf of a generic drug manufacturer or related industry seeking information on a specific element of generic drug product development or certain post-approval submission requirements.

In an introductory message, OGD director Iilun Murphy discusses the GDUFA 3 approval in 2022, scientific research on generic drugs, ANDAs and first generic approvals, international collaboration, and looking to the future.

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

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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