Lupin receives U.S. FDA tentative approval for apixaban oral suspension 1.25 mg/mL under the 505(b)(2) pathway, expanding anticoagulation options.
Written By: Rishabh Sonawane, BPharm
Reviewed By: Pharmacally Editorial Team
Lupin has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for apixaban oral suspension 1.25 mg/mL, an alternative liquid formulation of the oral anticoagulant apixaban. The product uses the 505(b)(2) regulatory pathway and could provide an additional administration option for adults who require anticoagulation but have difficulty swallowing tablets.
Liquid Formulation Expands Apixaban Administration Options
Apixaban is a direct oral anticoagulant (DOAC) that inhibits factor Xa, reducing thrombin generation and clot formation. It is the active pharmaceutical ingredient in Eliquis (apixaban), marketed by Bristol Myers Squibb and Pfizer.
Lupin’s formulation delivers apixaban as an oral suspension at a concentration of 1.25 mg/mL. A liquid formulation may be clinically relevant for patients who cannot reliably swallow conventional tablets, including some older adults and patients with swallowing difficulties.
The product is intended for adult patients requiring anticoagulation therapy. However, the company’s announcement does not provide a new clinical efficacy or safety dataset for the formulation.
505(b)(2) Pathway Supports Regulatory Development
Lupin pursued the product through the FDA’s 505(b)(2) pathway, a regulatory route that can allow an applicant to rely partly on information from previously approved drugs while providing data specific to the proposed product.
For apixaban oral suspension, the pathway is particularly relevant because apixaban already has an established clinical and regulatory history through approved tablet formulations. The new product therefore represents a formulation development program rather than the introduction of a new anticoagulant molecule.
The tentative nature of the FDA approval is also important. Tentative approval does not constitute final U.S. marketing approval, meaning the product cannot be treated as commercially available in the United States on the basis of this regulatory action alone.
No New Efficacy or Safety Findings Reported
Lupin’s announcement did not disclose any clinical trial results, comparative efficacy data, pharmacokinetic findings, or new safety outcomes for the oral suspension.
Accordingly, the regulatory milestone should be viewed primarily as a formulation and regulatory development achievement. The established clinical profile of apixaban provides the therapeutic context, while the oral suspension is intended to broaden how the active drug can be administered.
The company has not disclosed a final FDA approval date or specific commercial launch timeline in the announcement.
U.S. Manufacturing Planned in New Jersey
Upon final approval, Lupin plans to manufacture apixaban oral suspension at its facility in Somerset, New Jersey. The company said the U.S.-based manufacturing site will support production and supply of the formulation.
Vinita Gupta, CEO of Lupin, said the tentative approval reflects the company’s focus on differentiated medicines addressing patient needs. She highlighted the oral suspension as an expansion of administration options for an established anticoagulant.
Final Approval Remains the Key Milestone
The next major regulatory step is final FDA approval, after which Lupin could proceed toward commercial availability in the United States. The product’s potential clinical value will depend largely on its ability to provide a practical alternative for adults who require apixaban but face limitations with tablet administration.
For Lupin, the filing also adds a differentiated formulation to its U.S. portfolio while leveraging an established anticoagulant molecule and domestic manufacturing capacity.
Reference
Lupin Receives Tentative Approval from U.S. FDA for Novel Apixaban Oral Suspension, Lupin, 28 September 2026
About the Writer
Rishabha Sonawane, B.Pharm (LinkedIn) is healthcare writer with a strong interest in medical writing, regulatory affairs, clinical research, and AI-driven drug discovery. He has completed specialized training from the NIH and ICMR in clinical pharmacology, clinical research, and scientific writing. Passionate about evidence-based healthcare communication, he focuses on translating complex scientific research into clear, accurate, and engaging medical content.
