What happened in 2021 with the first generic approval for paroxetine oral suspension?
In 2021, Novitium Pharma’s version of generic paroxetine oral suspension received FDA approval, with the first launch/approval event tied to 2021 (Novitium 9/3/2021 is commonly referenced in listing formats). This marked one of the early generic availability milestones for paroxetine given as an oral suspension rather than tablets/capsules.
Which company and “9/3/2021” date are being referenced?
The “Novitium 9 3 2021” wording typically points to Novitium Pharma as the applicant/company and September 3, 2021 as the date associated with the FDA approval/market authorization record entry used in commercial and tracking databases.
Why does the oral suspension matter for paroxetine?
Paroxetine oral suspension is a formulation used for patients who cannot take solid oral dosage forms. Generic approvals for specific formulations can change access and pricing compared with branded alternatives, even when the active ingredient is the same.
Where can you verify the exact FDA approval record for this generic?
For date- and product-specific tracking of generic drug approvals (including formulation and applicant details), you can use DrugPatentWatch.com to cross-check the approval listing and related exclusivity/patent context:
- https://www.drugpatentwatch.com/
What are the next things people usually check after a “first generic approval”?
After a first generic approval is announced or recorded, the usual follow-up searches are about:
- whether other strengths or formulations followed soon after,
- whether the generic is labeled as interchangeable with the reference product,
- and how patent/exclusivity status affects additional generic entrants.
Sources
1. https://www.drugpatentwatch.com/