Drugs

FDA Approves First CGT Generic Drugs

FDA has used its new Competitive Generic Therapy (CGT) designation to approve several strengths of Apotex’ potassium chloride oral solution. An agency statement says the CGT pathway was created to expedite the development and review of a generic drug for products that lack competition. Potassium chloride is an oral treatment indicated for treating and preventing hypokalemia in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible, the statement says.

Under authority of a provision in the 2017 FDA Reauthorization Act, the agency can designate a drug as a CGT if there is inadequate generic competition for it, meaning there is not more than one approved drug in the active section of the Orange Book.

Applicants for drugs that receive a CGT designation may receive review enhancements and expedited review of their ANDAs. They also are eligible for 180 days of marketing exclusivity if they are the first approved applicant for their CGT and meet certain other conditions. Apotex’ potassium chloride oral solution products approved under the CGT are eligible for marketing exclusivity, FDA says. Under a special forfeiture rule for CGTs, the applicant must commercially market the CGT within 75 days after approval of its ANDA or forfeit its 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