Medis customers granted Pregabalin marketing authorization (MA) in Germany in record time
Medis has managed to close the Pregabalin DCP procedure in Germany within four months after submission and receive the marketing authorization (MA) within a week after the close of the procedure, securing its customers a unique position among the first generics on the market already in 2014.
This is the third time Medis is offering data exclusivity launches based on a fast registration process in Germany, the procedures for both Memantine and Entacapone/Levodopa/Carbidopa were also closed within 4 months after submission, reaffirming the industry-leading quality of the Medis dossiers. Pregabalin is used to treat epilepsy and Generalized Anxiety Disorder, among other things.
The registration effort, driven by the registration teams in Iceland and Germany as well as being a joint push from the Medis Launch team, the customers, and the manufacturing site in Bulgaria, has allowed Medis customers to be in the first generic wave of launches for this blockbuster molecule.
Medis customers will expect to launch Pregabalin into the German market in December. The timelines originally set out in this project all lined up in the end to deliver such a fantastic result for everyone involved, and an exciting market launch is taking shape, well before the start of 2015.