Catalent inks supply deal with Aucta and Upsher-Smith for generic Sabril
Catalent Pharma Solutions, a global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has reached a commercial supply agreement for Aucta Pharmaceuticals’ vigabatrin.
The agreement comes after a successful development program to formulate vigabatrin into a novel dosage form that employs Catalent’s proprietary FlexDoseSM services, according to the company.
Aucta's commercial partner, Upsher-Smith Laboratories will launch vigabatrin for oral solution under the brand name Vigadrone, a generic alternative to Lundbeck’s Sabril (vigabatrin) powder for oral solution.
Vigabatrin for oral solution is used for the treatment of Infantile Spasms (IS) in babies 1 month to 2 years of age, and for Refractory Complex Partial Seizures (CPS) used along with other treatments to treat adults and children 10 years and older.
Under the terms of the manufacturing agreement, Catalent undertook the FlexDose development program, integrating the development of granulated drug product with stick-pack dose design, packaging and commercial manufacture of vigabatrin at its 166,000-square foot flagship European manufacturing facility in Schorndorf, Germany.
This will be the first FDA Abbreviated New Drug Application to employ Catalent’s proprietary FlexDose services, and the first to be commercialized in Schorndorf.
“Catalent has over a decade of experience in developing, manufacturing and packaging stick pack products, which offer a number of advantages to improve the convenience of dosing and patient adherence of drug products,” Catalent oral drug delivery president Jonathan Arnold said, in a press statement.
The agreement comes after a successful development program to formulate vigabatrin into a novel dosage form that employs Catalent’s proprietary FlexDoseSM services, according to the company.
Aucta's commercial partner, Upsher-Smith Laboratories will launch vigabatrin for oral solution under the brand name Vigadrone, a generic alternative to Lundbeck’s Sabril (vigabatrin) powder for oral solution.
Vigabatrin for oral solution is used for the treatment of Infantile Spasms (IS) in babies 1 month to 2 years of age, and for Refractory Complex Partial Seizures (CPS) used along with other treatments to treat adults and children 10 years and older.
Under the terms of the manufacturing agreement, Catalent undertook the FlexDose development program, integrating the development of granulated drug product with stick-pack dose design, packaging and commercial manufacture of vigabatrin at its 166,000-square foot flagship European manufacturing facility in Schorndorf, Germany.
This will be the first FDA Abbreviated New Drug Application to employ Catalent’s proprietary FlexDose services, and the first to be commercialized in Schorndorf.
“Catalent has over a decade of experience in developing, manufacturing and packaging stick pack products, which offer a number of advantages to improve the convenience of dosing and patient adherence of drug products,” Catalent oral drug delivery president Jonathan Arnold said, in a press statement.