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Loteprednol etabonate - Bausch & Lomb

Drug Profile

Loteprednol etabonate - Bausch & Lomb

Alternative Names: Alrex; CDDD-5604; Lotemax; LOTEMAXSM; Loteprednol; Loteprednol etabonate; P-5604

Latest Information Update: 24 Oct 2021

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At a glance

  • Originator Pharmos Corporation
  • Developer Bausch & Lomb; IVAX Corporation; Meda
  • Class Analgesics; Androstadienes; Anti-inflammatories; Antiallergics; Eye disorder therapies; Small molecules
  • Mechanism of Action Glucocorticoid receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Allergic conjunctivitis; Ocular inflammation; Ocular pain
  • Phase II Keratoconjunctivitis sicca
  • Discontinued Allergic asthma; Allergic rhinitis; Skin disorders

Most Recent Events

  • 28 Jun 2019 First generic equivalent available in USA for Ocular inflammation
  • 01 Mar 2019 9261200: updated intro, KDM, dev atble and HE; as drug is alreday launched in USA and MR mentioned that "With the FDA approval of LOTEMAX SM, physicians can now prescribe to their patients our most advanced loteprednol etabonate formulation to date, indicated for the treatment of postoperative inflammation and pain following ocular surgery," so launched for these indications after approval info
  • 26 Feb 2019 Launched for Ocular inflammation (In adults) in USA (Ophthalmic)
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