Drugs

FDA Denies 2 Vanda Tasimelteon Petitions

FDA has denied petitions submitted by Vanda Pharmaceuticals on 1/25 and 1/27 asking that the agency revoke approval of ANDAs held by Teva and Apotex for generic forms of Hetlioz (tasimelteon) 20 mg capsules. The petitions claimed the ANDAs do not have the same labeling as the reference-listed drug and thus violated the law’s prohibition against “untrue statement(s) of material fact” and posed safety concerns.

In its denial letter, FDA said it did not find that approval of the generics violated the “same labeling” requirement because the generic container does not include braille or the associated instructions found in the reference-listed drug’s container labeling.

“The omission of braille on the generic tasimelteon products’ container labeling is a permissible difference due to difference in manufacturer,” FDA says. “Additionally, we do not find that omitting the special instructions ‘Dispense in original container’ and ‘Do not cover braille’ on the container labeling for the generic products violates the ‘conditions of use’ requirements, as they are not ‘conditions of use’ for Hetlioz or the generic tasimelteon 20 mg capsule products.”

FDA also did not find that either ANDA included an untrue statement of material fact related to the omission of braille or the associated instructions in their container labeling and said the labeling differences do not raise any safety concerns.

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