Drugs

Lannett Sues FDA Over ANDA Rescission

Lannett is suing FDA in DC federal court over a 5/17 letter in which the agency rescinded its approval of the company’s ANDA for the oral cancer drug temozolomide (Merck’s Temodar). FDA says that the approval was “mistakenly granted.” At issue is the agency’s recent Warning Letter to China’s Chongqing Lummy Pharmaceutical Co., which was to provide the active pharmaceutical ingredient for Lannett’s generic Temodar. The letter details CGMP violations found in an inspection and notes that the firm is under an import alert.

“Because an FDA drug approval is a constitutionally-protected property right,” the company suit says, “FDA’s governing statute requires notice and an opportunity for a hearing before the agency may rescind a previously-granted approval. FDA nonetheless rescinded Lannett’s drug approval without giving Lannett the hearing that the statute and the Constitution require. Lannett seeks the court’s intervention to set aside the rescission action, declare that the rescission action is unlawful, and enjoin FDA from rescinding the approval in the future without following hearing procedures required by law.”

The filing notes that Lannett submitted its ANDA 2/15/11 and FDA approved it 3/23/16, one week after its inspection at the Chongqing Lummy facility. The company announced 3/29 that it had received FDA approval and then received a 4/1 letter from the agency indicating that the plant would not be releasing any new temozolomide API to the U.S. market until the agency deemed the facility to be acceptable.

The company says that in a 4/5 conference call with agency officials it confirmed that the product had not been launched and that there was none on the market. It also said it would not distribute any product with an API from the Lummy plant. FDA reportedly asked the company to withdraw the ANDA and failing that said it could rescind its approval. Lannett did not agree to either option, it says. The company says it proposed to resolve the dispute through an ANDA supplement changing the API supplier. But on 5/17 it received the agency’s rescission letter.

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