Mylan NV (NASDAQ:MYL) has revealed that its generic version of Advair did not get the approval of the U.S. Food and Drug Administration. The pharmaceutical company did not, however, reveal why the Food and Drug Administration rejected its drug but only said that it was in the process of reviewing the response it had received from the regulator. Advair, which is used to treat chronic lung diseases and asthma, was developed by GlaxoSmithKline plc (ADR) (NYSE:GSK) and has gone on to achieve blockbuster status.
Delay in approval
Before the rejection a couple of analysts had warned of the possibilities of delay in getting an approval because Mylan’s generic version of Advair was the first of its kind to undergo a review by the FDA.
Having generated sales of over $1 billion every year for more than 15 years now, handling the threat posed by advair generics from rival drug producers will be one of first major challenges that GSK’s incoming chief executive officer, Emma Walmsley, will have to handle. Projections are that Advair’s sales will start to fall once generic versions of the drug hit the market.
Strict standards in the approval process
But GSK is not alone in worrying about the generics that could come online. Sandoz, the generics unit of Novartis has delayed in releasing an Advair generic and has consequently attempted to employ stalling tactics by raising concerns with the Food and Drug Administration over the rules that govern generics. Some analysts are even of the view that such rules are the reason behind the delays in the approval of an Advair generic.
One generic that won the approval of the U.S. Food and Drug Administration though is the version that was developed by Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA). The inhaler was, however, limited to cases of asthma and not the whole range of indications that Advair is prescribed for.
Besides the generic from Mylan, Hikma Pharmaceuticals has also developed another drug that is expected to get a response from the FDA before the end of May this year.
On Wednesday shares of Mylan N.V. fell by3.28% to close the day at $40.35 a share.
