Drugs

Agency Cites Dr. Reddy’s Again After Inspection

FDA 2/21 issued Dr. Reddy’s Laboratories a three-observation Form-483 after inspecting its Miryalaguda active pharmaceutical ingredients (API) plant in Telangana, India. The API plant was cited in a 2015 Warning Letter, and this presumably was a follow up inspection based on comments made late last year by senior company officials who indicated corrections had been made and they awaited reinspection.

“The audit of our API manufacturing plant at Miryalaguda, by the U.S. FDA, has been completed today (February 21, 2017). We have been issued a Form-483 with three observations, which we are addressing,” Dr. Reddy’s said in a stock exchange filing. The company declined to provide details on the cited observations.

The 2015 Warning Letter cited manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, and followed earlier inspections of these sites by the agency in 11/2014, 1/2015, and 2/2015. The company was sent a Warning Letter in 2011 after an API facility in Mexico was inspected. According to that letter, the firm did not validate analytical methods used to test APIs. It also had incomplete cleaning validation for non-dedicated manufacturing equipment, and its out-of-specification investigations did not include analysis of all available data.

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