Drugs

Recordati Wants NeoProfen ANDA Conditions

Recordati Rare Diseases (RRD), which is the NDA sponsor for NeoProfen (ibuprofen lysine) injection, 10 mg/ml, is asking FDA to require that any ANDA that references NeoProfen include measures to mitigate the risk of precipitate formation, such as using vials inert to the complexing of aluminum with ibuprofen, and to provide evidence demonstrating stability of ibuprofen lysine drug product without formation of precipitate in the vial.

The petition says that the company recalled NeoProfen in 2010 as a result of a visible precipitate found in the product vial. It was reintroduced in 2012 after the issue was resolved by transitioning to an inert vial.

FDA in 4/2013 denied the company’s request to amend its label to reflect the use of an inert vial to mitigate the risk of precipitate formation, the letter says. It reports that since then, one ANDA referencing NeoProfen has been approved by FDA and that manufacturer did not adopt use of an inert vial.

“Recent analyses commissioned by RRD performed at an independent laboratory demonstrate that visible precipitates are forming in the ANDA product,” the company says. “RRD is submitting this citizen petition out of concern that measures must be taken to protect the vulnerable patient population for whom this product is indicated — premature infants with patent ductus arteriosis — to assure that risk mitigation measures are implemented to address the risk of precipitate formation in the ANDA product and any future ibuprofen lysine products.”

The petition says that the standard it is requesting is a clear prerequisite to enhancing the safety of patients receiving ibuprofen lysine. In the absence of such a requirement, it says, any ANDA to NeoProfen should be rated as BX to NeoProfen in the Orange Book … based on insufficient information to support product safety.

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