Generics
First generic celecoxib approved by FDA
The US Food and Drug Administration (FDA) announced on 30 May 2014 that it had approved the first generic versions of celecoxib capsules.
Impact of price cuts on spending on hyperlipidaemic drugs in South Korea
Rapidly increasing pharmaceutical expenditures have become a constant challenge to the sustainability of healthcare systems across countries including Korea.
Sun Pharma’s Gujarat site under FDA import alert
Sun Pharmaceutical Industries’ (Sun Pharma) response to the US import ban on products produced at the company’s Gujarat site is inadequate, according to a warning letter issued by the US Food and Drug Administration (FDA) on 7 May 2014.
Generic atypical antipsychotic drugs in Belgium
Health authorities are continually looking to increase the utilization of low cost generics to save considerable monies without compromising care, given the ever increasing pressure on available resources. Pressures are driven by ageing populations, the continual launch of new premium-priced drugs and stricter clinical management targets. The quest is enhanced by the number of standard drugs losing their patents in recent years.
FDA’s faster approval of generics to benefit Indian drugmakers
Indian generics makers are set to benefit from performance goals set by the US Food and Drug Administration (FDA) as part of the Generic Drug User Fee Amendments of 2012 (GDUFA).
Novartis settles Gleevec lawsuit with Sun Pharma
Sun Pharmaceutical Industries (Sun Pharma) announced on 15 May 2014 that it had reached a settlement agreement with originator drug developer Novartis over litigation concerning generic Gleevec (imatinib mesylate).
Impact of delisting ARBs in Denmark
Health authorities are looking to increase the utilization of low cost generics to save considerable resources without compromising care. This includes Denmark [1].
Natco tries to block hepatitis C patent in India
Indian generics maker Natco Pharma (Natco) has asked the Indian patent office not to issue a patent for US-based Gilead Sciences (Gilead) new hepatitis C drug Sovaldi (sofosbuvir).
Pharmacists’ attitudes towards generics in Czech Republic
A study carried out in the Czech Republic found that whether pharmacists routinely carried out generics substitution depended on their familiarity with the relevant legislation and their attitude towards generics substitution [1].
Blood pressure generics to be included in FDA’s testing plans
The US Food and Drug Administration (FDA) is planning an extensive study of blood-pressure drugs after receiving thousands of complaints from doctors and patients.
