Manufacturing problems are again standing in the way of a drug launch, with the FDA holding off approval of Allergan's ($AGN) new migraine treatment until problems at an inhaler plant are sorted out.
Allergan said today it expects the FDA will insist on a re-inspection of the Exemplar Pharma plant that fills the inhalers before it approves the product, Reuters reports. The FDA has had concerns with the manufacturing process before when MAP Pharmaceuticals ($MAPP) sought approval. Allergan bought MAP in January for about $958 million. The company said it has responded to the agency's concerns but has not yet heard back.
The drug is Levadex, an inhaled version of an existing drug, dihydroergotamine, which is typically given by nasal spray or by injection at a headache center or hospital. The drug was reformulated by MAP Pharmaceuticals.
MAP ran into the same issues last year when it applied for approval. In March 2012, it said that problems with chemistry, manufacturing and controls (CMC), as well as questions about its third-party manufacturer, were noted in an FDA inspection that led the FDA to forestall approval of Levadex.
Other companies have faced similar problems. Impax Pharmaceuticals ($IPXL) said in January that in a complete response letter, the FDA "requires a satisfactory re-inspection of the company's Hayward facility as a result of the warning letter issued in May 2011" before it will approve Impax's NDA for an extended-release capsule formulation of carbidopa-levodopa, for the symptomatic treatment of Parkinson's disease.
- here's the Reuters story