Generics
Indian FDA wants to increase use of generics
The Commissioner of Indian Food and Drug Administration (FDA) has denied allegations by physicians and pharmacists in India that the bioavailability of generic drugs is doubtful.
Actavis makes agreement for generic abuse-deterrent oxycodone
US generics maker Actavis (formerly Watson) announced on 26 April 2013 that it had reached an agreement with Purdue Pharma (Purdue) to settle all outstanding patent litigation related to Actavis’ generic version of Purdue’s abuse-deterrent formulation of OxyContin (oxycodone).
Quality of generics in South Africa
A study of the quality of generic medicines in South Africa has shown large differences in the perception and the actual quality of generics [1].
Daiichi Sankyo and Ranbaxy announce synergy in Brazil
India-based Ranbaxy Laboratories (Ranbaxy) and its Japanese parent company Daiichi Sankyo announced on 17 April 2013 plans to integrate their generic and brand-name drug business operations in Brazil.
Generics applications under review by EMA – 2013 Q1
Last update: 6 September 2013
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 27 EU member states and in Norway, Iceland and Liechtenstein. 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].
FDA is dragging its feet over oxycodone generics
The US patent for Purdue Pharma’s (Purdue’s) blockbuster painkiller OxyContin (oxycodone) expired on 16 April 2013, but FDA has yet to approve any generic versions. Now, FDA has announced that it will not approve any generics of the original formulation OxyContin.
Mylan gains approval for generic of Valeant’s Zovirax
Generics giant Mylan announced on 3 April 2013 that its subsidiary Mylan Pharmaceuticals had received final approval from FDA for its abbreviated new drug application (ANDA) for acyclovir ointment 5%.
AstraZeneca settles rosuvastatin lawsuit
UK-based AstraZeneca announced on 25 March 2013 that it had entered into a deal concerning US patent infringement litigation against Actavis (formerly known as Watson Pharmaceuticals) and EGIS Pharmaceuticals with respect to Actavis’ generic rosuvastatin zinc product.
Cost savings from use of generic medicines in Ireland
Ireland has one of the lowest usages of generics in the EU. However, in order to try to address this, the country introduced a new bill – Health (Pricing and Supply of Medical Goods) Bill 2012 – on 16 September 2012. Authors Dunne et al. discuss how the proposed changes could affect health care in Ireland [1].
New entrant to generic injectables market
Medical technology company Becton Dickinson announced on 28 March 2013 that FDA had approved the first drug in its line of prefilled generic injectables. This can only be good news for FDA who has been fighting to alleviate drug shortages in the US, most of which are due to shortages in generic sterile injectables.
