Drugs

Par Sues FDA Over BPI Epinephrine Approval

Par Pharmaceutical is asking the DC federal court to grant a temporary restraining order to block FDA’s grant of final approval to a BPI Labs NDA supplement for an epinephrine product that cites Par’s Adrenalin (epinephrine) as the reference-listed drug. Par says there is a 30-month statutory stay that prevents such an agency final approval.

Par says it sued BPI for patent infringement on 8/29/2023 in a Florida federal court. It says that the suit triggered a 30-month stay prohibiting FDA from granting final approval to the BPI application until 1/18/2026.

FDA granted final approval of the BPI application on 2/14, Par says in its suit. It says the agency determined that a 30-month stay does not apply to Par’s patent infringement action because information on the two contested Par patents was submitted to its NDA on 1/14/2016 and 4/12/2916, after the 12/4/2012 date on which BPI’s NDA was originally submitted.

Par says a memo it received from FDA indicated that the agency was changing its practice concerning new strength supplements for ANDAs, so that a 30-month stay would not be available for new strength supplements for ANDAs for patents submitted after the original ANDA was submitted.

The suit says FDA changed the rules after Par’s 30-month stay was in force.

The company asks the court for a temporary restraining order and a preliminary injunction against FDA’s approval of the BPI supplement. It also asks for an order to FDA to convert its final approval of the BPI submission into a tentative approval until the conclusion of the 30-month stay.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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