Generics
Teva gains approval for generic breast cancer and anti-depressant drugs
The Israeli generics’ giant Teva Pharmaceuticals is racing ahead in the generics game with the announcement of the approval by the FDA of two new drugs for treatment of breast cancer and depression.
Bioequivalence testing for generics
Bioequivalence studies, consisting of single-dose pharmacokinetic evaluations, are required for the registration of most generic drug formulations. In general, bioequivalence testing provides a useful comparison for different products containing the same active ingredient. Bioequivalence studies therefore play a key role in the development of new generic products as well as in the post-marketing phase of innovator products.
Astra Zeneca losing generic esomeprazole battle
On 17 June 2010, AstraZeneca announced that its efforts in Canada to stop the launch of a generic version of its patented, stomach-acid-relief drug Nexium (esomeprazole), were rejected by the Canadian court.
Bayer sues Teva over generic Yaz contraceptive
On 15 June 2010, German-based Bayer Schering Pharma (Bayer) announced that it was suing the Israeli generic giant, Teva Pharmaceuticals (Teva), for false advertising and patent infringement in connection with Teva’s generic oral contraceptive, Gianvi. Teva’s product is sold as a generic version of Bayer’s leading oral contraceptive Yaz.
FDA creates new division to speed up generic approval times
As the FDA’s Office of Generic Drugs (OGD) struggles to keep up with its growing backlog of abbreviated new drug approvals (ANDAs), the office is creating a new chemistry division that it hopes will allow speedier generic drug approvals.
Ranbaxy launches generic antiplatelet agent Prasita in India
On 10 June 2010, Indian-based Ranbaxy Laboratories Limited (Ranbaxy) announced the launch of a generic version of Prasugrel in India. The product, called Prasita, is an antiplatelet agent for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention.
Sanofi-aventis blocks generic Allegra
On 14 June 2010, a US court backed sanofi-aventis and Albany Molecular Research in their bid to prevent Dr Reddy’s selling a generic version of the anti-allergenic medication, Allegra-D 24 Hour (fexofenadine HCl/pseudoephedrine HCl).
Teva forces Dutch market to use pre-filled MTX syringes
Until recently, the generic disease-modifying anti-rheumatic drug methotrexate (MTX) was available in The Netherlands in large vials, of which (hospital) pharmacists prepared ready-to-use (RTU) syringes for the weekly treatment of patients with rheumatoid arthritis (RA).
Are generic medicines in Europe too expensive?
by Professor Steven Simoens, Research Centre for Pharmaceutical Care and Pharmaco-economics, Katholieke Universiteit Leuven, Leuven, Belgium
Is the quality of generic medicines under pressure?
“You get what you pay for” runs the old adage, and concerns are being expressed that a number of firms providing clopidogrel in Europe have all sourced the active ingredient from the same Indian firm, Glochem Industries Ltd, which has failed a quality inspection.
