Amneal Pharmaceuticals, Inc. initiated the U.S. commercialization of TEPADINA® (thiotepa) for Injection 200 mg in a patented multichambered bag. This new “Lyobag” presentation, developed and manufactured by ADIENNE Pharma & Biotech SA, a Swiss-based biopharmaceutical company focused on oncology and rare diseases, was FDA approved, for the same four indications as the existing vial presentation. The addition of the 200 mg multichamber bag format to the 15 mg and 100 mg vials broadens the company’s U.S. portfolio for this brand.
TEPADINA 200 mg is the first FDA-approved combination product to incorporate ADIENNE’s proprietary multichamber flexible container freeze-drying technology. This closed system include aseptic filling as well as lyophilization directly into the bag, providing a ready-to-infuse, needle-free format for administering cytotoxic drugs.
Its key features include:
- Less Time Required: Eliminates manual reconstitution and dilution steps, fastening up preparation with its Ready-to-use, needle-free format.
- Improved safety: Closed system helps reduce the risk of dosing errors and protects healthcare professionals from exposure to cytotoxic agents.
- Less waste and cost: Limits the need for reconstitution equipment, hoods or cleanroom environments; supports combination therapies from a single device.
- Enhanced stability: Maintains product stability for up to 5–7 days when refrigerated and 56 hours at room temperature; the system preserves the efficacy and stability of the active ingredient throughout administration via its high-performance oxygen and moisture barrier.
The design is made in order to enhance safety, simplify preparation and improve drug stability in clinical settings. The new bag presentation utilizes the same common J-code (J9340) used for existing thiotepa vial presentations.
Executive Statement
According to Andy Boyer, Executive Vice President, Chief Commercial Officer, this innovative delivery system represents an important advancement in how cytotoxic therapies are prepared and administered. They are proud to bring this first-of-its-kind presentation of TEPADINA to healthcare professionals in the U.S., supporting safer and more efficient care through our partnership with ADIENNE