Drugs

FDA Warns Centaur on CGMP Issues

A 1/30-2/8 FDA inspection at the Centaur Pharmaceuticals drug manufacturing facility in Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations in the production of finished drugs. A 7/25 Warning Letter says the specific violations were:

failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would affect the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements; and
failing to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

FDA says the firm’s responses to the two observations were inadequate. The agency acknowledges Centaur’s commitment to temporarily suspend the production and distribution of certain drugs intended for the U.S. market. It also acknowledges recalls of alprazolam and clobazam tablets manufactured at the facility that remain within expiry.

Centaur is to notify FDA before it resumes manufacturing drugs for the U.S. market.

The company was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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