Drugs

Milestone Reached on Competitive Generic Therapies

CDER Office of Generic Drugs (OGD) has reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation. The Competitive Generic Therapy program encourages the development and marketing of generic drugs for products with little to no competition. “Additionally, more than 80% of the first-approved applicants who were eligible for Competitive Generic Therapy exclusivity started marketing the drug within 75 days after FDA approval,” OGD says.

The FDA Reauthorization Act of 2017 created the pathway by which the agency may, at the request of an applicant, designate a drug with “inadequate generic competition” as a competitive generic therapy (CGT). At the applicant’s request, FDA may also expedite the development and review of an ANDA for a drug designated as a CGT.

In 2020, FDA finalized the guidance, Competitive Generic Therapies, describing the process that applicants should follow to request the designation of a drug as a competitive generic therapy (CGT). The document also gives the criteria for designating a drug as a CGT. Contents of the guidance are Introduction, Background, Competitive Generic Therapy Designation, Considerations for Expedited Development and Review of Competitive Generic Therapies, and Competitive Generic Therapy Exclusivity.

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