The United States Food and Drug Administration have denied Allergen Inc the distribution of a new migraine drug, according to Reuters.
The FDA said the drug will not be allowed to hit stores or pharmacy’s because of the canisters used to take the inhaled drug. The FDA has expressed concerns about the way the canisters are filled before they are shipped out.
In the past, the FDA has shown explicit concerns about the company Exemplar Pharma LLC. The company is responsible for putting the Allergan drug into the canisters before they are shipped.
Allergen believes the FDA will insist on an additional inspection of the facility before the new drug is approved. According to Allergan, it bought the Exemplar under $20 million. The company placed put its own people at Exemplar to oversee operations.
Allergen said it has addressed the issue however the FDA has not had adequate time to respond.
Allergen expects a response for the FDA near the end of the year. Regardless, the company does not see the drug—called Levadex—affecting it either way. Projections for the sale of the drug were expected to be very small.
Levadex is an inhaled variation on the drug dihyroergotamin. Dihyroergotamin is usually administered through injection or inhaling at a hospital or at a facility where headaches are treated.
According to Thompson-Reuters data, analysts expect sales of Levadex to reach close to $300 million by 2015.
According to the National Headache Foundation, about 30 million people in the United States suffer from migraines.
