Generics
FDA revokes Ranbaxy’s esomeprazole and valganciclovir ANDAs
India-based generics maker Ranbaxy Laboratories (Ranbaxy) announced on 6 November 2014 that the company had been informed by the US Food and Drug Administration (FDA) of the agency’s decision to revoke its approval for the company’s generic versions of AstraZeneca blockbuster acid-reflux drug Nexium (esomeprazole) and F. Hoffman-La Roche’s cytomegalovirus treatment Valycte (valganciclovir).
Mylan latest to recall blood pressure generics
US generics giant Mylan has become the latest in a line of generics companies that have faced recalls of the blood pressure medication metoprolol.
Changes to pharmaceutical policy during an economic recession
The use of antipsychotic medicines across Finland and Portugal following the recent economic recession have been analysed in order to gauge the impact of contrasting pharmaceutical policy interventions put in place over that time.
FDA names and shames firms for failing to pay generics fees
No less than 28 generics makers are currently on the US Food and Drug Administration’s (FDA) GDUFA (Generic Drug User Fee Amendments) Facility Arrears List for failing to pay generics fees for 2013 and 2014.
Generics firms carve their way to victory
US generics company Mylan has won a court battle over brand-name drugmaker Hospira, meaning it is now free to resume distribution of generic Precedex (dexmedetomidine injection).
Reference pricing and generics in Finland
Reference pricing and the extension of generics substitution have produced substantial savings in antipsychotic medication costs in Finland. The daily cost of treatment with clozapine, risperidone, olanzapine or quetiapine was cut by at least a third in just one year following the adoption of reference pricing for these drugs.
Canada bans imports from three API facilities in India
Just days after Canada’s federal department responsible for health was reported to be in talks with the US Food and Drug Administration (FDA) about Canadian generics maker Apotex, Health Canada has announced that it is to ban imports from two of Apotex’s facilities and from one site belonging to IPCA Laboratories in India.
Generics in Taiwan: urban–rural disparity
A study of the urban–rural disparity of prescribing generic versus brand-name drugs in Taiwan has found that the generics prescribing ratio of the most popular anti-hypertensive (high blood pressure) medicines is reversely associated with the level of urbanization [1].
Thirty years of generics in the US
On 24 September 2014, the US Food and Drug Administration (FDA) celebrated 30 years of generics in the US.
Actavis agrees to continue making Alzheimer’s drug for now
Actavis has agreed to keep selling a top Alzheimer’s disease drug for 60 days so US patients will not be forced to switch to a newer, more expensive form of the drug.
