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Generics

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First Sabril Rival Sees FDA Deliver On Prioritizing Competition

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.

Generic Drugs Approvals

European Council Brings SPC Manufacturing Waiver A Step Closer

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.

Europe Manufacturing

Wockhardt Wins Review Of Ban On Indian Combination

Evidence put forward by manufacturers to support fixed-dose combinations must be considered by an advisory committee to India’s government, the Delhi High Court has ordered in a verdict favouring Wockhardt.
India Regulation

Remodulin And Revlimid Rivals Join France’s Répertoire

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.

France Generic Drugs

Court Clears Teva After At-Risk Budesonide Entry

Teva has escaped potential damages from its ‘at risk’ US launch of budesonide extended-release tablets after a US Court of Appeals upheld a previous non-infringement ruling.
Intellectual Property Gastrointestinal

Sandoz’ Hexal Avoids German Fulvestrant Use Patent

Any prescribing of Hexal’s generic fulvestrant in Germany for uses covered by AstraZeneca’s patent would be so minimal as to be irrelevant, a regional court of appeals has ruled.
Germany Cancer
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