According to generic inhalation device developer Merxin, the FDA has reviewed data for the company’s MRX001 blister multidose DPI and suggested that the agency would accept the MRX001 as an AB rated substitutable version of Diskus.
The company shared this quote from the FDA’s response: “After reviewing your controlled correspondence submitted on May 3, 2019, the OGD’s preliminary review is that the information submitted as part of the comparative (threshold) analyses, including the sample devices provided, suggests that your proposed device constituent may be appropriate for submission as part of an abbreviated new drug application (ANDA) referencing ADVAIR DISKUS.”
In addition to the MRX001, Merxin’s other devices designed for generics include the MRX003 capsule DPI and the MRX04 soft mist inhaler. In February 2019, Merxin announced that it would co-develop inhaled cannabis products with Perlen Packaging that would deliver Merxin formulations via Perlen’s BLISTair single use dry powder inhaler.
