FDA approves Teva's generic EpiPen in blow to Mylan
- Teva Pharmaceutical's generic version of EpiPen just got approved by the FDA on Thursday.
- Teva's stock is up 5.7% in Thursday afternoon trading.
- The news is a blow to Mylan NV, and its stock dropped 1% following the announcement.
The U.S. Food and Drug Administration on Thursday approved Teva Pharmaceutical Industries Ltd's generic version of Mylan NV's EpiPen for the emergency treatment of allergic reactions.
"Today's approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval," FDA Commissioner Scott Gottlieb said.
The news comes a week after Mylan announced that it will conduct a strategic review of the company due a tough environment for generic drugmakers. Mylan has also faced a lot of controversy over the past several years.
This includes an EpiPen shortage problem, a dramatic EpiPen price hike over the last decade, several class-action lawsuits, and an accusation that it was overcharging the US government by $1.27 billion for EpiPens.
Israeli multinational pharmaceutical company Teva had applied for a generic EpiPen in early 2016. At the time, the application was rejected by the FDA.