Two big-time drugmakers are having to put their plans on hold thanks to problems with contract manufacturers, with GlaxoSmithKline ($GSK) facing a prolonged drug shortage and Allergan ($AGN) enduring an FDA rejection.
For Allergan, the FDA is putting off approval of the migraine treatment Levadex, citing problems at an inhaler plant operated by CMO Exemplar Pharma, FiercePharmaManufacturing reports. It's the same issue MAP Pharmaceuticals faced before Allergan bought it in January for about $958 million, and the drugmaker said it has addressed the agency's concerns and awaits a response.
GSK, on the other hand, is struggling to deal with shortages of Horizant, its restless leg syndrome treatment, according to Outsourcing-Pharma. The company is blaming an unspecified issue with a CMO for the delay in production, warning that the drug will remain in short supply until June.
The two are hardly the first to grapple with delays caused by outsourcers. Last year, Navidea Biopharmaceuticals ($NAVB) took a beating on the Street after the FDA delayed its approval of Lymphoseek, a diagnostic agent, over problems with a third-party manufacturer.
- read Outsourcing-Pharma's story on GSK
- here's the FiercePharmaManufacturing writeup on Allergan