Imprimis Rx LLC
FDA issued a warning letter to Imprimis Rx LLC (Carlsbad, CA) regarding promotional materials for its compounded ophthalmic drug product Pred-Moxi-Brom (PMB), published in two professional periodicals in early 2021. The agency found the materials made false or misleading claims about FDA approval status (implying bulk drug substances were FDA-approved), unsubstantiated superiority claims over other drug products, and misleading safety presentations that omitted known risks of the active ingredients. FDA cited violations of 21 U.S.C. 352(bb), 321(n), and 331(a) and demanded written corrective action within 15 working days, warning that failure to comply may lead to further regulatory action.
Flagged claims (9)
In our clinic's experience, few patients have had to discontinue treatment because of allergies, burning sensation, or other adverse events.
Pred-Moxi-Brom is also a prednisolone acetate suspension medication; these suspensions are preferred by ophthalmologists, owing to better corneal penetration and higher overall anti-inflammatory effects than prednisolone sodium phosphate solutions.
Unlike off-the-shelf prescription medications made by the major drug manufacturers, compounded prescription drugs are specifically created and 'made to order' from two or more existing medications already approved by the U.S. Food and Drug Administration (FDA) for safety and efficacy.
As a compounded eye drop comprising medications already approved by the FDA, PMB also costs less than the same ingredients purchased separately.
The bottom line: Pred-Moxi-Brom doesn't just represent a win-win for physicians and patients; it represents a new and higher standard in the treatment of postsurgical pain and inflammation.
Although generic medications are available, they can potentially cause unknown adverse effects. Pred-Moxi-Brom virtually eliminates all these challenges with just one drop.
By its ability to improve quality of care and the patient experience, PMB maximizes patient compliance and reduces pharmacy callbacks for generic substitutions.
It's worth noting that a compounded medication like PMB demonstrated quality that is equal to, if not higher than, drugs produced by the major pharmaceutical companies.
Pred-Moxi-Brom's tolerability is also high.
Required actions (2)
We request that ImprimisRx cease any violations of the FD&C Act.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Such documentation should include a listing of all other promotional communications for Pred-Moxi-Brom that contain representations such as those described above and an explanation of any plan for discontinuing such communications, or for ceasing distribution of Pred-Moxi-Brom.
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