Latest Generics News

Pharmac highlights role of generics in 2008 review

Tuesday 6 January 2009

Actavis manufacturing enjoined at three US sites
Actavis has agreed to a consent decree with the US government barring it from manufacturing and distributing drug products at three Actavis Totowa facilities in New Jersey until they demonstrate compliance with good manufacturing practice requirements.
Monday 5 January 2009

US approval for Watson's Mircette generic

Wednesday 31 December 2008

CHMP accepts bioequivalence of two Hexal products
The EU's CHMP has settled a disagreement between regulators in several European countries over the bioequivalence of Hexal's branded generic Sabumalin (salbutamol 100μg metered dose aerosol inhaler) and GlaxoSmithKline's Sultanol...
Wednesday 31 December 2008

CHMP recommends harmonising labels for three products
The EU's CHMP has recommended harmonising the labels on two products containing ramipril and another containing sertraline in all of the markets where they are licensed under national procedures.
Wednesday 31 December 2008

KV Pharmaceutical halts generic tablet shipments

Tuesday 30 December 2008

FDAAA trial registration requirements clarified

Tuesday 30 December 2008

US FDA revises vancomycin generic bioequivalence standards

Monday 29 December 2008

Generics making public inroads in Japan
Patients in Japan are increasingly asking for and receiving generic drugs, a new survey suggests.
Thursday 18 December 2008

Mixed trends propel consolidation in global generics
Continued consolidation in the generic pharmaceuticals industry is one of the main trends identified by speakers at the 11th annual meeting of the International Generic Pharmaceutical Alliance in Geneva, Switzerland.
Tuesday 16 December 2008

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