Drugs

Perrigo Approval for First Generic ProAir HFA

FDA has approved a Perrigo Pharmaceutical ANDA for the first generic of Teva’s ProAir HFA (albuterol sulfate) inhalation aerosol for treating or preventing bronchospasm in patients four years of age and older with reversible obstructive airway disease. It is also indicated for preventing exercise-induced bronchospasm in patients four years of age and older.

The approval is part of FDA’s actions to increase approval of complex generics. In 2016, the agency issued a revised draft product-specific guidance for proposed generic albuterol sulfate metered dose inhalers, including drug products referencing ProAir HFA. Among other things, the draft guidance provides bioequivalence recommendations.

An FDA release notes that this year it will continue to advance additional policies to promote generic competition for complex generic drug products. “Among other steps, the agency intends to publish additional guidance documents to aid in the development of specific complex generic drug products,” it says. “The FDA also plans to publish a series of guidances to address regulatory and scientific challenges that make it generally more difficult to develop complex generic drug products because of their complex formulation or mode of delivery.”

FDA says it also intends to issue draft guidance with recommendations on establishing active ingredient sameness. In addition, it is going to help advance “new analytical tools and in vitro tests that may provide additional accurate, sensitive and reproducible ways to support development of complex generic drugs,” the release says. “Better tools can reduce complex generic drug development time and cost and can inform regulatory decisions.”

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