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Prioritizing the approval of generics of medicines with little or no competition has been a key part of the FDA’s efforts to support access and reduce costs to patients; the agency has just granted Teva approval for the first generic version of Lundbeck’s Sabril (vigabatrin) 500mg tablets.
A proposed SPC manufacturing waiver – which would allow generic and biosimilar manufacturing within Europe during the SPC period – has taken a step closer to being realized after the European Council approved a mandate for negotiations with the European Parliament. However, it remains uncertain whether key elements desired by the off-patent industry will fall into place.
Almost 20 new generic groups – including rivals to Flecaine, Inegy, Remodulin and Revlimid – have been added to France’s répertoire of generic equivalents following the latest update by local medicines agency ANSM.
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