Hikma Pharmaceuticals plc
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Latest From Hikma Pharmaceuticals plc
Hot on the heels of multiple US FDA approvals for rivals to the blockbuster ADHD brand Vyvanse, generics suppliers have confirmed launches – and with drugs in this category currently facing shortages, developers are eyeing significant demand.
A US FDA tentative approval for Aurobindo’s dolutegravir combination generic for children should increase access under the PEPFAR program and aid sales. On a Q1 earnings call, renewed efforts to restructure Eugia, biosimilar launch plans and fallouts of oral drug shortages and damage to Pfizer’s US injectables warehouse were discussed.
Hikma has struck two deals in the MENA region, outlining agreements with Rakuten Medical and SK Biopharmaceuticals that focus on innovative assets.
Since FDA has approved Sezaby there is no reason for continued use of unapproved phenobarbital sodium products, firm tells FDA. Sun cites risks to neonates from three excipients in these products. The seizure drug has been marketed since 1940.
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