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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

DateArticle
Jun  6, 2019Motif Bio Announces Path Forward for Iclaprim following Receipt of FDA Meeting Minutes
Feb 14, 2019Motif Bio Receives Complete Response Letter From The FDA
Aug 14, 2018Motif 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, 2018Motif Bio Submits NDA for Iclaprim
May  1, 2018Motif Bio REVIVE-2 Phase 3 Study Results with Iclaprim Published in Peer-reviewed Journal, Antimicrobial Agents and Chemotherapy
Mar  2, 2016First Patient Dosed in Iclaprim Phase 3 Trials to Treat Skin Infections
Sep  3, 2015FDA Grants Fast Track Designation for Iclaprim
Jul 22, 2015FDA QIDP Designation for Motif’s Lead Antibiotic Candidate Iclaprim for ABSSSI
Jan 20, 2009FDA Issues Complete Response Letter for Iclaprim
Nov 21, 2008Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome
Oct 14, 2008Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008
May 16, 2008Arpida Announces FDA Acceptance of the Iclaprim New Drug Application
Mar 19, 2008Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections

Further information

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