AstraZeneca will discontinue the production of Pulmicort (budesonide) 100 and 200 µg/dose HFA pMDI (pressurised metered dose inhaler) due to complex manufacturing issues related to technical aspects of the device, which prevents the ongoing manufacture of the product. This issue is not related to the active ingredient, budesonide, or any other AstraZeneca product.
The manufacturing decision will take effect immediately; however, patients can continue using the Pulmicort pMDI 100 and 200 µg strength until their current supply is finished.
“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,” said David Smith, executive vice president, global operations and IS, AstraZeneca.
Pulmicort pMDI is manufactured using product-specific processes and components, the combination of which is not used with any other AstraZeneca respiratory products; therefore, this is a unique issue to Pulmicort pMDI.
AstraZeneca is working closely with the appropriate regulatory authorities, Healthcare Professionals (HCPs), and informing manufacturers of similar asthma medications, where appropriate, to ensure all patients continue to receive the appropriate alternative treatment. Patients currently taking Pulmicort pMDI should contact their physicians about alternative treatments. Healthcare professionals should review their patients’ needs and prescribe a suitable alternative medication.
Pulmicort pMDI is only approved in certain countries. Additional announcements from AstraZeneca will follow in countries where Pulmicort pMDI is approved in order to provide further guidance to patients and physicians.
Other AstraZeneca respiratory products, including Pulmicort Turbuhaler, Pulmicort Respules and Pulmicort Flexhaler are not affected because they use different devices or device components, and should continue to be used where sold in accordance with approved prescribing information. Other AstraZeneca pMDI products such as Symbicort budesonide/formoterol fumarate dihydrate) pMDI and Vannair (budesonide/formoterol) are also not affected.
AstraZeneca sets the highest standards in quality for all its products and is committed to maintaining such standards.
Pulmicort (budesonide) is an inhaled anti-inflammatory glucocorticosteroid for initiation and maintenance treatment of bronchial asthma in infants, children and adults (minimum age for recommended use in children/ infants varies according to approved prescribing information).
Pulmicort is available in a range of formulations: Pulmicort Turbuhaler (dry powder inhaler), Pulmicort pMDI (pressurised Metered Dose Inhaler, CFC free), and Pulmicort Respules (suspension for nebulisation). Trade names and availability of formulations may differ between countries.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease.