Iclaprim FDA Approval Status
FDA Approved: No
Generic name: iclaprim
Dosage form: Intravenous Injection
Company: Motif Bio plc
Treatment for: Skin and Structure Infection
Iclaprim is an investigational broad-spectrum diaminopyrimidine antibiotic in development for the treatment of acute bacterial skin and skin structure infections (ABSSSIs).
Development timeline for iclaprim
| Date | Article |
|---|
| Jun 6, 2019 | Motif Bio Announces Path Forward for Iclaprim following Receipt of FDA Meeting Minutes |
| Feb 14, 2019 | Motif Bio Receives Complete Response Letter From The FDA |
| Aug 14, 2018 | Motif Bio Announces FDA Acceptance of New Drug Application With Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections |
| Jun 14, 2018 | Motif Bio Submits NDA for Iclaprim |
| May 1, 2018 | Motif Bio REVIVE-2 Phase 3 Study Results with Iclaprim Published in Peer-reviewed Journal, Antimicrobial Agents and Chemotherapy |
| Mar 2, 2016 | First Patient Dosed in Iclaprim Phase 3 Trials to Treat Skin Infections |
| Sep 3, 2015 | FDA Grants Fast Track Designation for Iclaprim |
| Jul 22, 2015 | FDA QIDP Designation for Motif’s Lead Antibiotic Candidate Iclaprim for ABSSSI |
| Jan 20, 2009 | FDA Issues Complete Response Letter for Iclaprim |
| Nov 21, 2008 | Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome |
| Oct 14, 2008 | Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008 |
| May 16, 2008 | Arpida Announces FDA Acceptance of the Iclaprim New Drug
Application |
| Mar 19, 2008 | Arpida Submits New Drug Application for Intravenous Iclaprim for
Treatment of Skin Infections |
Further information
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