Tentative U.S. FDA Approval for Novel Apixaban Oral Suspension 1.25 mg/mL
Lupin has received tentative approval from the U.S. FDA for its New Drug Application for Apixaban Oral Suspension 1.25 mg/mL, shared via the 505(b)(2) pathway.
- Product
- Apixaban Oral Suspension 1.25 mg/mL
- Regulatory Status
- Tentative approval from U.S. FDA
- Update Pathway
- 505(b)(2) pathway
- Manufacturing Location
- Somerset, New Jersey facility
- Indication
- Anticoagulation therapy for adults, including those with difficulty swallowing tablets
What was announced
Lupin said it has received tentative approval from the U.S. FDA for its New Drug Application for Apixaban Oral Suspension 1.25 mg/mL, shared through the 505(b)(2) pathway.
About the product
- Apixaban is the active ingredient in Eliquis® of Bristol Myers Squibb, used as an anticoagulant (blood thinner).
- Lupin's version is an oral liquid rather than a tablet, giving an alternative administration option for adult patients, including those who may have difficulty swallowing tablets.
Manufacturing
Upon final approval, the product will be manufactured at Lupin's Somerset, New Jersey facility, using the company's U.S.-based manufacturing capability.
What tentative approval means
Tentative approval indicates the FDA has found the application to meet requirements for approval, but final approval and commercial launch follow later. Revenue contribution would begin only after final approval and launch.
Company context
Lupin distributes products in over 100 markets, operates 15 manufacturing facilities and 6 research centers, with a workforce of over 26,000 professionals.
The company positions this as part of building a differentiated portfolio in complex and specialty products.
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More numbers
- Apixaban oral suspension strength1.25mg/mL
- Markets where products distributedover 100 markets
- Manufacturing facilities15
- Research centers6
- Workforceover 26,000 professionals
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