Drugs

Court Remands Amgen Dispute to FDA for Further Consideration

The Washington DC District Court has remanded to FDA an Amgen lawsuit against the agency over its denial to grant pediatric exclusivity for the company’s Sensipar (cinacalcet hydrochloride). In its complaint, Amgen argued that FDA’s decision to grant an earlier pediatric exclusivity award to Johnson & Johnson’s Ortho Tri-Cyclen (ethinyl estradiol; norgestimate) was inconsistent with its denial for Sensipar. The court agreed and remanded the dispute to FDA for the “limited purpose of addressing whether the agency’s prior decision granting pediatric exclusivity for Ortho Tri-Cyclen is consistent with its decision denying pediatric exclusivity for Sensipar and, if not, whether there is a reasoned explanation for the disparate outcomes.”

In a 1/26 court-issued opinion, judge Randolph Moss said Amgen has a point that the Ortho Tri-Cyclen decision may be inconsistent. In an earlier reconsideration decision for Sensipar, FDA distinguished the agency’s grant of exclusivity for Ortho Tri-Cyclen on the ground that studies conducted by Ortho Tri-Cyclen’s sponsor, Johnson & Johnson (J&J), met all of the terms of the written request. “As Amgen argues, however, it is — at best — unclear from the administrative record whether that premise is correct,” the judge said while siding with Amgen’s contention that women enrolled in a related J&J study did not meet the study criteria.

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