Generics
Endo removes Opana ER opioid from the market
The US Food and Drug Administration (FDA) requested that Endo International plc (Endo) remove its opioid medication Opana ER from the market, due to concerns over the ‘public health consequences of abuse’.
Generics prices increase when competition decreases
A US-based retrospective cohort study has found that generics prices increase when competition is low or non-existent [1].
AAM tries to block ‘unconstitutional’ drug pricing law
The Association for Accessible Medicines (AAM) has filed a lawsuit against the Attorney General of Maryland in an attempt to block a recently passed law which could affect national commerce in the US and harm the market for generic drugs, which saved Maryland over US$4 billion in 2016.
Impax launches new high-strength ADHD generics
Impax Laboratories Inc (Impax) has received US Food and Drug Administration (FDA) approval for additional strength capsules of generic Focalin XR (dexmethylphenidate hydrochloride), which was originally marketed by Novartis and is used to treat attention deficit hyperactivity disorder (ADHD).
Follow-up study finds generic tacrolimus safe for kidney transplant patients
Researchers from Portugal, who carried out a long-term follow-up study, have found that switching stable kidney transplant patients to generic tacrolimus is safe [1].
Generics in the pipeline for 2017 in the US
Since the Hatch-Waxman Act was passed in 1984, the approval process for generics has been simplified. The law created an abbreviated approval pathway for generics making it easier for generics to enter the market and expanding access to important — often life-saving — drugs.
FDA lists drugs without generics to increase competition
The US Food and Drug Administration (FDA) announced on 27 June 2017 that it had taken ‘two new, important steps’ to increase competition and encourage the entry of generics in the US.
UK introduces new law to control generic drug prices
A new law introduced in the UK is seeking to clarify and extend the government’s powers to regulate the cost of medicines and medical supplies and to collect sales and pricing information from pharmaceutical companies.
Baxter and Dorizoe make deal for generic injectables
US-based healthcare company Baxter International (Baxter) and contract research and development organization Dorizoe announced on 14 June 2017 that they have made a deal for generic injectables.
FDA approval for generics of ADHD drug Strattera
The US Food and Drug Administration announced on 30 May 2017 the approval of the first generic versions of Strattera (atomoxetine).
