Drugs

Depomed Orange Book Listing ‘Uninterpretable’ by FDA

Responding to a Depomed 1/29 citizen petition, FDA says that it must deny the petition at this time because it cannot interpret contradictory information on a patent use code for the company’s Nucynta ER (tapentadol). The petition asked the agency to stay final approval of any ANDA referencing Nucynta ER that fails to submit a patent certification for the ’130 patent.

The response says that FDA must deny the petition “because the information you placed before the agency makes your patent use code for ’130 patent uninterpretable. Based on statements in your petition, FDA believes that Depomed might misunderstand FDA’s regulations and practice regarding appropriate use codes.”

FDA says that Depomed’s inconsistent statements about the approved methods of using Nucynta ER claimed by the patent render its use code uninterpretable. Further, it says the use codes submitted for the ’130 patent currently are associated only with FDA’s approval of an NDA supplement and not to the drug’s first indication.

“We recommend that Depomed evaluate its use code for the ’130 patent in light of the conflicting record before the agency regarding the ’130 patent and in light of this response,” FDA concludes. “If Depomed does not submit a new patent declaration form (FDA-3542) for the ’130 patent with the signed certification statement within 15 calendar days from the date of this response letter, FDA will revert to the last interpretable use code for the ’130 patent submitted for Nucynta ER, which is the use code submitted prior to Depomed’s 9/2015 amendment.”

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