21 Jan 2014
In late April, Ipsen Pharma (Ipsen) informed the Regulatory Agencies of the European Union (EU), ESPE and the public of a market shortage of Increlex® (mecasermin) in the EU from early August 2013. The shortage was due to difficulties in manufacturing the active ingredient of Increlex® in the USA by Ipsen’s third party manufacturer. On December 18th Ipsen announced that Lonza has successfully re-manufactured the active ingredient of Increlex® (mecasermin).
The European Medicines Agency (EMA) as well as the EU Member States’ national competent authorities have been informed that Ipsen is preparing for the reintroduction of Increlex® in the EU. As of today all National Agency of EU countries where Increlex® is marketed have approved resupply and the product is available again for prescription. Resupply in the US is still pending.
Ipsen is actively working with its third party manufacturer and the FDA to bring the Increlex back to market in the US as soon as possible.
For any questions you may contact Ipsen at the following email address: [email protected]
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