FDA Gives Tentative Approval to Lupin for Alternative Formulation of BMS Drug
What happened
Lupin Limited received tentative approval from the United States Food and Drug Administration for its New Drug Application for Apixaban Oral Suspension 1.25mg/mL. This formulation is an oral liquid version of apixaban, the active ingredient in Eliquis® manufactured by Bristol-Myers Squibb. If final approval is granted, the product will be manufactured at Lupin's facility in Somerset.
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Why it matters
The approval provides an alternative administration option for adult patients needing anticoagulation therapy. The introduction of this generic formulation increases competition for Bristol-Myers Squibb's Eliquis®.
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Who's involved
- United States Food and Drug AdministrationAgency that granted tentative approval for the drug formulation.
- Bristol-Myers SquibbCompany whose original drug, Eliquis®, is the active ingredient in the approved formulation.
- Vinita GuptaCEO of Lupin Limited, who announced the tentative approval.
- SomersetLocation where the new product will be manufactured upon final approval.
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- Bristol-Myers SquibbSpeculative
Bristol-Myers Squibb might face reduced revenue due to increased generic competition for Eliquis®.
How this reaches others
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The entities involved
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United States Food and Drug Administration
agency of the US Department of Health and Human Services
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Bristol-Myers Squibb
American pharmaceutical company