Generics

Teva launches generic testosterone

Generics/News | Posted 08/09/2017

Teva Pharmaceutical Industries (Teva) has announced the exclusive launch of generic testosterone, previously marketed as Axiron by Eli Lilly and Co, on the US market.

Barriers to generics substitution in the Middle East

Generics/Research | Posted 01/09/2017

Although most pharmacists in Lebanon are in favour of generic drug substitution, fewer than half have actually implemented the policy, according to a study carried out by researchers from the American University of Beirut [1].

FDA receives record number of generic drug applications for 2017

Generics/General | Posted 01/09/2017

Just part way through 2017, the US Food and Drug Administration (FDA) has already received a record number of generic drug applications, surpassing the totals for both 2016 and 2015.

Generic drug substitution in Lebanon

Generics/Research | Posted 25/08/2017

A new study reports on Lebanon’s recently introduced generic drug substitution and unified prescription policy, a country which spends among the most on pharmaceuticals in the Middle East. The study explored attitudes of community pharmacists towards the idea of the policy and its current implementation [1].

Senior US senator calls on insulin manufacturers to justify high prices

Generics/General | Posted 25/08/2017

Senator Amy Klobuchar, senior senator from Minnesota, has written to three major diabetes drug manufacturers asking them to justify recent price hikes, which are placing increasing pressure on patients in the US.

Adamis gains FDA approval for its EpiPen rival

Generics/News | Posted 25/08/2017

Adamis Pharmaceuticals Corporation (Adamis) announced in June 2017 that they have received US Food and Drug Administration (FDA) approval for their EpiPen competitor Symjepi.

WHO prequalifies first generic hepatitis C drug

Generics/General | Posted 18/08/2017

The World Health Organization (WHO) has prequalified the first generic drug to treat hepatitis C. The antiviral agent sofosbuvir will be manufactured at a lower cost by Mylan.

Endo removes Opana ER opioid from the market

Generics/News | Posted 18/08/2017

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

Generics/Research | Posted 11/08/2017

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

Generics/General | Posted 11/08/2017

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

Generics/News | Posted 11/08/2017

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

Generics/Research | Posted 14/07/2017

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

Generics/Research | Posted 07/07/2017

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

Generics/General | Posted 07/07/2017

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

Generics/General | Posted 30/06/2017

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

Generics/General | Posted 23/06/2017

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

Generics/News | Posted 23/06/2017

The US Food and Drug Administration announced on 30 May 2017 the approval of the first generic versions of Strattera (atomoxetine).

FDA targets rising drug prices by increasing generics competition

Generics/General | Posted 16/06/2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb is advocating reducing drug costs by approving cheaper generics faster.