Generics
Mylan/Aspen launch generic busulfan injection
US generics giant Mylan Pharmaceuticals (Mylan) and its partner, generics manufacturer Aspen Pharmacare Holdings (Aspen), announced on 4 December 2017 that it had launched generic Myleran (busulfan) single-dose vial in the US, after receiving final approval from the US Food and Drug Administration (FDA).
Drugmakers waking up to potential value of branded generics
Pharma companies are making a move into what may become a lucrative sector – branded generics. The concept is simple – take a generic drug, repackage it and add marketing and hey presto you have a branded generic.
Generic metformin bioequivalent in healthy volunteers in Nigeria
Researchers from Nigeria’s Obafemi Awolowo University have found generic metformin sourced in the country to be ‘not inferior’ to originator metformin [1].
REMS issues come under FDA spotlight
US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb has once again chastised brand-name drug companies that deliberately delay federal procedures and use regulations to delay the entry of generics competitors.
Perceptions and attitudes towards generics in South Korea
A survey of the perception and attitude of South Korean physicians towards generics has shown that not much has changed despite the introduction of a new pharmaceutical policy in 2012 [1].
FDA tentatively approves pemetrexed generic
Eagle Pharmaceuticals (Eagle) announced on 27 October 2017 that it had been granted tentative approval from the US Food and Drug Administration (FDA) for its generic version of Eli Lilly’s lung cancer blockbuster Alimta (pemetrexed).
Kenya needs to increase use of generics to combat rising costs
Kenyan medical insurance management firms are advising that they will only pay for generics and not brand-name prescriptions.
Mergers could be causing price increases for generics
How mergers and acquisitions in the generics sector can be a factor in drug shortages and increasing prices was a question addressed by researchers from Carleton and McGill Universities in Canada [1].
EMA approval for tacrolimus generic
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 12 October 2017 that it had recommended granting marketing authorization for the tacrolimus generic tacforius.
New use for old generic could treat rare cardiovascular condition
Researchers from Canada and the UK may have found a new use for an old generic drug: treatment of the rare cardiovascular condition, pulmonary arterial hypertension (PAH).
