Drugs

Bayer Reiterates Position on Apotex ANDA

A Bayer citizen petition reiterates the company’s request that FDA confirm that it will stay final approval of an Apotex ANDA for over-the-counter azelastine HCl nasal spray 205.5mcg/spray that cites Bayer’s Astepro Allergy as the reference-listed drug. The 9/29 petition says it is substantively the same as a 4/5 petition that FDA denied 9/2 on non-substantive grounds and without comment on whether it would take the action requested.

Bayer says it is submitting the second petition “to ensure that FDA carefully considers these important issues” before approving the Apotex ANDA.

The petition says the agency should apply a 30-month stay of approval of the ANDA because all three of the statutory prerequisites for a stay have been met. The three prerequisites are, it says:

Apotex made a Paragraph 4 certification to each of three Bayer patents listed in the Orange Book in connection with the Bayer NDA;
Bayer and a co-plaintiff initiated timely litigation alleging Apotex’s infringement of the three patents; and
Bayer submitted to FDA the required information for the patents before Apotex submitted its original ANDA.

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