Generics
Access to medicines in Shaanxi province China
Although generics in the Shaanxi province of China are significantly cheaper than their brand-name equivalents there is still room for improvement, according to a study of the prices and availability of selected medicines in the province [1].
Generics game changer for Ireland
A new pharmacy in Dublin, Ireland, is offering customers savings of up to 80% on the price of drugs by focussing on generics. The news comes in light of legislation passed by both houses of Ireland’s parliament in May 2013, which encourages wider use of generics and generics substitution [1].
Switching to generic cyclosporine A after heart transplant safe
Cyclosporine A is an immunosuppressant drug widely used in organ transplantation to prevent rejection. A study of switching between originator and generic drugs showed that the generic was well tolerated and that there were no differences between the originator and generic drugs [1].
FDA issues Ranbaxy with Form 483 for violations at Toansa plant
Ranbaxy Pharmaceuticals (Ranbaxy) is coming under scrutiny from US Food and Drug Administration (FDA) once again. One of the company’s key Indian facilities at Toansa, Punjab, has been issued a Form 483 by FDA.
ANI Pharmaceuticals acquires 31 generics from Teva
US-based brand-name and generics manufacturer ANI Pharmaceuticals (ANI) announced on 26 December 2013 that it had acquired 31 previously marketed generic drugs from Teva Pharmaceutical Industries (Teva).
Sandoz gains Danish approval for innovative asthma inhaler
Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 18 December 2013 that it had received Danish marketing authorization for AirFluSal Forspiro, a novel inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).
Generics applications under review by EMA – 2013 Q4
Last update: 20 January 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].
First generics of Cymbalta approved by FDA
The US Food and Drug Administration (FDA) announced on 11 December 2013 that it had approved the first generic versions of duloxetine delayed-release capsules, a prescription medicine used to treat depression and other conditions.
Recent reforms and initiatives in Scotland to encourage the prescribing of generic drugs and the implications
Scotland has introduced a number of reforms and initiatives in recent years to enhance the prescribing of low cost generics, thereby saving money to help fund increased volumes and new premium priced drugs [1, 2]. However, there have been situations where no specific initiatives have been introduced [3, 4]. Consequently, analysis of the various initiatives in Scotland could provide examples to other countries seeking additional measures to further enhance their prescribing efficiency.
Sandoz makes deal with Shire for authorized Adderall XR generic
Shire announced on 2 December 2013 that its subsidiary Shire US had entered into an agreement to supply an authorized generic version of its attention deficit hyperactivity disorder (ADHD) drug Adderall XR (amphetamine, dextroamphetamine mixed salts) to Sandoz.
