Drugs

FDA Loses Court Case Over Generic Minocin

The Washington DC District Court has ruled against FDA in granting summary judgment to plaintiff Melinta Therapeutics that suspends the approval of a generic version of the company’s Minocin (minocycline), which treats bacterial infections, manufactured by Nexus Pharmaceuticals. In seeking FDA approval of its ANDA in 2020, a required Paragraph 4 was sent to Melinta via Fed Ex delivery, but it was never signed by a company representative acknowledging receipt of delivery, according to the court opinion.

The Fed Ex delivery notice shows that it was delivered 12/8/2020, but with no receipt signature by Melinta because the delivery service suspended its normal signature process due to Covid-19 restrictions. Melinta further claims that it did not actually receive the notice until 3/31/2021, after which it had 45 days to initiate a patent infringement suit against Nexus. FDA disagreed with Melinta’s argument and denied a related citizen petition that sought confirmation of the 3/31 delivery date, and it subsequently approved the Nexus ANDA.

The court says it agreed with Melinta that the term “signature proof of delivery,” as used in 21 CFR § 314.95(e), “unambiguously requires the signature of the recipient or a designated representative, and therefore that FDA is not entitled to deference in its interpretation that it does not.”

The court further ordered FDA’s approval of Nexus’s ANDA to be vacated and remanded the case to the agency for further action consistent with the opinion.

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