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Slow response to internet sales of fake pharmaceuticals

If you are reading this news online, you are surely aware that many sites claim to sell “generic medicines” “without prescription” over the internet. Police and authorities have noticed as well, but do not know how best to tackle these lucrative scams.

Tentative approval for more new Sun Pharma generics

Sun Pharma is not slowing down with the number of new generic medication introductions. The latest generics to come out of the company include versions of riluzole hydrochloride and rosuvastatin.

Pharma price-fixing under renewed investigation

Some of the world’s biggest drug companies are having once again to face up to price-fixing allegations thanks to the Supreme Court of California. These allegations were dismissed by a lower court two years ago. The suit claims that the 18 drug manufacturers, including Pfizer, GlaxoSmithKline, AstraZeneca, Merck and Eli Lilly amongst others, not only set artificially high prices, but also conspired to keep cheaper Canadian drugs off the US market and to stave off generic competitors.

Generics in The Netherlands

The market for generic medicines in The Netherlands ambulatory health care is developing, with more being used, more companies supplying generic medicines and prices tumbling. This is despite the restriction on the reimbursement of hypnotics and tranquilisers on the basic insurance from 1 January 2009. Reimbursement in this category fell by 25%, from Euros 612 million in 2008 to Euros 459 million in 2009.

International trends in generics: India

South Africa, home to 5.7 million HIV-positive people – more than any other country in the world – gives AIDS patients free drugs, most of which are generics that come from India. This is just one country, but representative of many that are keen to buy low-priced generic medicines from India. So much so that India now produces a quarter of the world’s generic medicines.

What is ‘tentative approval’ and how does it affect generics?

Tentative approval by the FDA enables generics access to poor nations under a US initiative, which allows sale of generics to treat conditions where there is a significant public health impact, even though the originator drugs are still under patent protection.

Drug recalls and generic medicines

In 2009 there were a record number of drug recalls according to Health Reform Watch. There were an amazing 1,742 drug recalls in 2009 compared to 426 in 2008.

Post-marketing pharmacokinetic bioequivalence between generic and branded amoxicillin formulations

Amoxicillin is a moderate-spectrum, bacteriolytic, β-lactam antibiotic used to treat bacterial infections caused by susceptible microorganisms. It is usually the drug of choice within the class because it is better absorbed, following oral administration, than other β-lactam antibiotics.

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.

Generic substitution of cyclosporin sometimes undesired

The bio-equivalence criteria of the Dutch Medicines Evaluation Board (CBG-MEB) offer insufficient guarantee for a safe substitution of generic medicines in transplantation medicine, argue Internist-Nephrologist/Clinical Pharmacologist Teun van Gelder of the Erasmus MC and Professor of Surgery Robert Porte of the University of Groningen –both members of the board of the Nederlandse Transplantatie Vereniging (NTV) – in Pharmaceutisch Weekblad of 29 January 2010.

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