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FDA Rejects Migraine Drug Levadex (Dihydroergotamine)

Agency cites manufacturing issues (Apr. 16)

The FDA has declined to approve the new drug application (NDA) for Levadex (dihydroergotamine, Allergan, Inc.) inhalation aerosol for the acute treatment of migraine in adults, citing manufacturing problems.

During a previous inspection, the agency had noted concerns with Exemplar Pharma, LLC, which would manufacture the aerosol canisters for Levadex. To secure a supply chain, the drug’s developer, Allergan, purchased the company on April 12, 2013, and appointed senior members of its own team to oversee the facility. Allergan expects that the FDA will want to re-inspect the site before making another approval decision.

The FDA also expressed reservations regarding the manufacturing process for the final filled canisters.

Allergan has stated that it is committed to “vigorously address” the FDA’s concerns. The company estimates that the next agency action will occur before the end of 2013.

Dihydroergotamine is an ergot alkaloid that constricts blood vessels in the brain.

Current migraine treatments include the triptans Imitrex (sumatriptan, GlaxoSmithKline), Axert (almotriptan, Johnson & Johnson/Almirall), and Zomig (zolmitriptan, AstraZeneca).

Sources: Allergan; April 16, 2013; and Reuters; April 16, 2013.

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