QIDP Designation and Fast Track Status – Mino-Lok by Citius Pharma

QIDP Designation

The Qualified Infectious Disease Product (QIDP) designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the US Congress in July 2012, for the purpose of encouraging pharmaceutical companies to develop new antimicrobial drugs to treat serious and life-threatening infections.

Receiving QIDP designation means that our Mino-Lok® product is eligible for additional FDA incentives in the approval and marketing pathway, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.

In October 2015, the FDA notified us that our Mino-Lok product had received a QIDP designation.

  • Priority Review: Reduces the NDA review time from 12 months to 8 months.
  • Market Exclusivity: NDAs for QIDPs are granted an additional five years of market exclusivity under Hatch-Waxman for a combined total of 10 years regardless of patent protection.
FDA Grants QIDP Designation to LMB for Mino-Lok, a Novel Antibiotic Lock Therapy in Development to Treat Catheter Related Blood Stream Infection (CRBSI)

Leonard Meron Biosciences, Inc. (LMB)* 
Oct 12, 2015, 05:25 ET

* Leonard-Meron Biosciences, Inc. (LMB) is a subdivision of Citius Pharmaceuticals, Inc.

Fast Track Status

Fast Track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. The purpose of Fast Track is to get important new drugs to the patient earlier. Determining whether a condition is serious is a matter of judgment by the FDA, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.

In October 2017, Citius Pharmaceuticals received official notice from the FDA that the clinical development program for Mino-Lok was designated as Fast Track.

Citius Pharmaceuticals, Inc. Receives "Fast Track" Designation By FDA For Mino-Lok Investigational Trial

Citius Pharmaceuticals, Inc.  
Oct 31, 2017, 08:00 ET