Generic Advair won’t be available anytime soon after the FDA sent a a complete response letter (CRL) to Mylan Pharmaceuticals regarding the generic Advair they were trying to put out on the market. The CRL is essentially a bad news notification on drug approvals. Mylan did not say if this would be a short term delay or a longer term problem. Either way this gives GSK, the makers of Advair, more time to hang onto revenues from its blockbuster medication for asthma, Advair.
Mylan said in a statement that they will review the response from the FDA and give an update on the generic Advair once its completed the full review and discussed the FDA’s feedback. Mylan’s generic Advair would have been the first substitutable version of Advair. GSK has warned multiple generic drug makers that the approval process may be difficult as the Advair Diskus inhaler technology is hard to copy. Novartis’ Sandoz is also trying to make its own generic Advair too.
Advair was the first in its class of asthma combination medications. It combines an inhaled steroid and a long acting beta agonist (LABA). It revolutionized the treatment for patients with moderate to severe persistent asthma, as it combined two essential treatment options for patients who were not controlled with inhaled corticosteroids alone. Since Advair was released other companies have come out with their own combination asthma medications, Symbicort and Dulera. Anticipating the inevitable release of generic Advair, GSK has come out on the market with Breo, this is a combination asthma medication as well, but it only needs to be taken once daily.
All of these combination medications come with a hefty price tags that some insurance plans do not cover. That is why the delay of the generic advair will hurt many asthma sufferers who can not afford these medications presently. Although it is inevitable that generic Advair will be available in the near future.
If you suffer from asthma, speak to an allergy specialist to see which medication is right for you. Combination asthma medications are not right for everyone and your asthma doctor would be able to determine which treatment is optimal for you after taking a full history and performing appropriate testing.
Breo for Asthma now available as a once daily treatment