NEW YORK —
Allergan said Tuesday morning that the FDA had declined to approve the drug, Levadex, because of concerns about the manufacturing of the inhaler used to dispense it.
Levadex is a new version of DHE, or dihydroergotamine, which has been used to treat acute migraines for decades but which is usually given by intravenous infusion, requiring patients to get to a hospital during a migraine attack.
Levadex, by contrast, is inhaled using devices similar to those used for asthma, allowing patients to treat themselves at home.
In January, Allergan agreed to pay $958 million to acquire MAP Pharmaceuticals, the Silicon Valley biotechnology company that developed Levadex. The deal closed last month.
The FDA had declined to approve Levadex in March 2012, a decision MAP said was tied to the agency’s concerns about the inhaler. Allergan’s agreement to purchase MAP before waiting for the FDA’s second decision this month suggested that it was confident that Levadex would be approved.
Allergan said Tuesday that the FDA, in its letter explaining its decision to decline approval for the second time, expressed concerns about findings from an inspection of the company that was filling the canisters. The agency also had concerns about the manufacturing process for the final filled canisters.
The FDA does not publicly discuss its conversations with applicants, citing requirements for confidentiality.
Allergan said it had already taken steps to fix the problems. This month it acquired the canister-filling company Exemplar Pharma for less than $20 million and installed its own executives to run the operation.
“Allergan is committed to vigorously address the concerns raised by the FDA,’’ the company said in its news release. It said it hoped it would have another chance to win approval at the end of this year.
Allergan, based in Irvine, Calif., is most known for its drug Botox, a bacterial toxin used to treat various medical conditions and to smooth wrinkles.