FDA approves Mylan’s generic Advair
FDA approves Mylan’s generic of Advair asthma treatment
(Reuters) – The U.S. Food and Drug Administration (FDA) approved Mylan NV’s generic version of GlaxoSmithKline-developed blockbuster asthma treatment Advair, driving shares of Mylan 7 percent higher on Wednesday.
Mylan received approval to market its generic inhaler in three dosages for the twice-daily treatment of asthma in patients aged four years and older, the FDA said.
The FDA has declined to approve several Advair knock-offs in the past from drugmakers including Novartis AG, Hikma Pharmaceuticals and Mylan itself, whose generic was rejected last year.
In the United States, more than 26 million people are known to have asthma, and about seven million of these people are children, the FDA said.
British-listed GSK reported revenue of about $4.19 billion from Advair in 2017.
Even though the potential revenue opportunity from a generic version of Advair has fallen over the past several years, Wednesday’s approval is nonetheless important to Mylan, Citi analyst Liav Abraham said.
Analysts at Leerink said they expect Mylan to launch its generic in February and about $170 million in 2019 revenue from the treatment.
Shares the Mylan closed 7.2 percent at $30.82 on the Nasdaq on Wednesday.
Reporting by Aakash Jagadeesh Babu in Bengaluru