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FDA grants approval for generic lansoprazole Generics/News | Posted 03/12/2010

Teva Pharmaceutical Industries announced on 18 October 2010 that it had received FDA approval for its Abbreviated New Drug Application for its generic version of Takeda's Prevacid (lansoprazole) So...

FDA generics division officer joins Teva Pharma News | Posted 03/12/2010

Teva Pharmaceutical Industries has added to its team Mr Gary Buehler, former head of the generics division at the FDA, The Wall Street Journal reported. Mr Buehler joins Teva as vice president of r...

Teva brings another action against Mylan Generics/News | Posted 03/12/2010

In October 2009, Teva Pharmaceutical Industries filed a lawsuit against Mylan for infringement of multiple patents, with respect to patents on its glatiramer acetate drug–Copaxone. The patents cove...

What is the incremental cost-effectiveness ratio (ICER)? Generics/General | Posted 03/12/2010

The incremental cost-effectiveness ratio (ICER) often comes up when talking about drug comparisons, but what is it and how does it relate to medicines?

Fewer generic applications in the EU in 2010 Reports | Posted 26/11/2010

Figures published by the EMA in October 2010 on centralised procedures show a reduction in the number of generic applications filed and finalised this year up to September 2010. Although this numbe...

Endo acquires US generics’ giant Qualitest Pharma News | Posted 26/11/2010

Endo Pharmaceuticals is buying US generics’ giant Qualitest Pharmaceuticals for about Euros 850,000 in cash to expand its portfolio of pain drugs. This is its second acquisition in as many months;...

US guidelines for generics Guidelines | Posted 26/11/2010

Last update: 1 August 2011The regulatory body for approval of medicines in the US is the FDA.

Market access for biopharmaceuticals and biosimilars: a case study Biosimilars/Research | Posted 26/11/2010

Filgrastim is one of the first biopharmaceuticals for which biosimilars have entered the market. This case study illustrates the health economic challenges and the issues that arose in the R &...