AstraZeneca has announced that it will stop manufacturing the Pulmicort 100 and 200 µg/dose budesonide HFA pMDI. According to the company, the device has caused “complex manufacturing issues” and the resulting difficulty is causing it to stop production immediately.
David Smith, Executive Vice President, Global Operations and IS said, “We have exhausted all potential solutions in our efforts to continue supplying this medicine. The time required to fully resolve the technical issues is highly uncertain. We believe it is our responsibility to communicate our decision swiftly, as it is in the patient’s best interest to find an alternative medication as soon as possible.” AZ will continue to produce its other dosage forms of Pulmicort, including the Respules, Flexhaler, and Turbuhaler.
SkyePharma developed the formulation for the Pulmicort pMDI and derives ~5% of its revenue from the product. The company’s CEO, Axel Müller, tried to put the decision in the best light, saying:
“AstraZeneca’s decision to cease manufacture of PULMICORT® pMDI because of problems related to the device is disappointing. However, it is one of 12 approved and marketed products which use our technology and we anticipate continued progress in our pipeline of development products this year, including FlutiformTM, which is currently being assessed by European regulators.”
Read AstraZeneca’s press release.
Read SkyePharma’s press release.
