Drugs

New Requests in Radius Petition Supplement

Radius Health has submitted a supplement to its 4/22 petition regarding its Tymlos (abaloparatide) injection. The supplement asks that FDA take these actions, in addition to those requested in the original petition:

refuse to grant an A-therapeutic equivalence rating to any ANDA or 505(b)(2) NDA referencing Tymlos for subcutaneous use unless the application demonstrates the same incidence of anti-abaloparatide antibodies, neutralizing antibodies, and cross-reactive antibodies as Tymlos using a clinically validated immunoassay;
record the agency’s assessment of the scientific and legal issues raised in the petition and supplement when it considers any ANDA or 505(b)(2) NDA that references Tymlos; and
consider the issues raised by the petition and supplement in developing guidance and reviewing applications for follow-on versions of parathyroid hormone analogs, and in the agency’s final guidance on the evaluation of therapeutic equivalence.

The original petition asked FDA to:

refuse to grant an A-therapeutic rating to any ANDA or 505(b)(2) NDA that references Tymlos for subcutaneous use unless it demonstrates a stable pH value of 5.1 to 5.2;
refuse to grant an A-therapeutic rating to any ANDA or 505(b)(2) NDA that references Tymlos unless it contains the degradant Beta-Asp10-abaloparatide in an amount less than 0.5% of its drug substance; and
refuse to file any ANDA for recombinant abaloparatide.

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