Follitropin alfa biosimilar - Teva

Drug Profile

Follitropin alfa biosimilar - Teva

Alternative Names: Ovaleap; XM 17

Latest Information Update: 02 Nov 2015

Price : $50

At a glance

  • Originator Ratiopharm
  • Developer Teva Pharmaceutical Industries
  • Class Follicle stimulating hormones; Infertility therapies; Peptide fragments; Pituitary gonadotropins; Recombinant proteins
  • Mechanism of Action Ovarian follicle stimulants
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Female infertility

Most Recent Events

  • 15 Oct 2014 Launched for Female infertility in Portugal and Czech Republic (SC)
  • 30 Sep 2013 Registered for Female infertility in European Union (SC)
  • 31 Jul 2013 CHMP of the EMA recommends approval of Teva Pharmaceutical Industries' biosimilar of follitropin alfa for Female infertility in European Union
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