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Dr Reddy’s US drug pricing comes under scrutiny

Dr Reddy’s Laboratories, the India-based generics drugmaker, has been asked to share drug-pricing information with the attorneys general of California and Texas in November 2014. The two US States take their lead from an investigation into generics pricing at the national level.  

Health Canada clamps down on GMP compliance

Canada’s federal health department Health Canada has written to its licensed drug and active pharmaceutical ingredients (API) manufacturers worldwide reminding them of their regulatory responsibilities and obligations. The department plans to step up planned and unplanned inspections of facilities, with the aim of taking timely and appropriate action where needed.

FDA cash to develop hard-to-copy generics

The US Food and Drug Administration (FDA) is offering US$850,000 to research teams working on generics development. Funds will be split between three programmes: bioequivalence testing for long-acting periodontal drugs; developing methods for assessing long-acting injectable generics; and dissolution methods for long-acting levonorgestrel intrauterine system. Funds may be extended for a further two years.

Pfizer warns UK doctors not to prescribe generic Lyrica for pain

Pharma giant Pfizer is fighting hard to protect one of its brand-name products, this time its epilepsy treatment Lyrica (pregabalin).

Generics applications under review by EMA – December 2014

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein, and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

GPhA comments on generics’ legislation and Trans-Pacific Partnership

Mr Ralph G Neas, President and CEO of the US Generic Pharmaceutical Association (GPhA), has commented on proposed legislation for generics in the US, as well as on provisions in the Trans-Pacific Partnership that he believes could impede access to medicines.

EU Member States suspend generics approvals due to problems at CRO

The European Medicines Agency (EMA) announced on 5 December 2014 that some Member States have decided to suspend the marketing authorizations of medicines that have been authorized on the basis of studies conducted at India-based contract research organization (CRO) GVK Biosciences (GVK Bio) Hyderabad site.

Investigation into huge price increases for generics in the US

Two US Congressmen have sent letters to 14 drug manufacturers, including several major Indian firms, requesting information about the escalating prices they have been charging for generics.

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.

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.