Drugs

Osmotica Asks BE Test for Venlafaxine

Osmotica Pharmaceutical is asking FDA to require that any ANDA seeking approval of venlafaxine HCl extended-release tablets 225 mg and referencing the company’s NDA-approved product demonstrate in vivo bioequivalence using the 225 mg strength. A 12/9 citizen petition says the agency generally recommends that in vivo bioequivalence be demonstrated in the highest strength. “There does not appear to be a reason to depart from that general practice for venlafaxine HCl extended-release tablets,” it says.

The petition also notes that FDA scientists recently published results from modeling and simulation studies showing that a waiver of in vivo bioequivalence for the 225 mg strength likely would be inappropriate for ANDAs that use openable matrix or similar formulations that differ from Osmotica’s osmotic technology, due to the absence of acceptable dissolution data.

Osmotica says it produces the drug in 37.5 mg, 75 mg, 150 mg, and 225 mg strengths. The 150 mg strength is listed in the Orange Book as the reference-listed drug. In 2010, the petition says, FDA approved Sun Pharma Global’s ANDA for venlafaxine HCl in all strengths except 225 mg. That ANDA referenced Osmotica’s product. No generic version of the 225 mg strength has been approved, the company says.

The petition says FDA should implement the bioequivalence requirement for the 225 mg strength by designating that strength as an additional reference-listed drug in the Orange Book and by revising the product-specific bioequivalence guidance for venlafaxine HCl extended-release tablets to recommend in vivo testing of the 225 mg strength.

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

Read more

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