Generics

Taiwan TWi gains FDA approval for generic nifedipine

Generics/News | Posted 11/04/2014

Taiwan’s TWi Pharmaceuticals (TWi) announced on 7 April 2014 the approval of its abbreviated new drug application (ANDA) for generic nifedipine by the US Food and Drug Administration (FDA).

Prescribers, pharmacists and patients in Turkey believe generics differ from originators

Generics/Research | Posted 04/04/2014

A study carried out by Toklu and co-authors from the University of Istanbul, Turkey, has shown that many prescribers, pharmacists and patients in Turkey believe that generics differ from their originators [1].

Dr Reddy’s launches generic amlodipine/atorvastatin

Generics/News | Posted 04/04/2014

Indian generics giant Dr Reddy’s announced on 27 March 2014 the launch of its generic amlodipine/atorvastatin tablets in the US.

The non-financial benefits of generics substitution

Generics/Research | Posted 28/03/2014

Switching between different generic brands of metformin is a good cost-effective approach that does not adversely affect the quality of care for patients with type 2 diabetes, according to the results of a retrospective study in Taiwan.

EGA calls for removal of competition and trade barriers for generics

Generics/General | Posted 28/03/2014

The European Generic medicines Association (EGA) is calling on the EU to remove barriers to competition and free trade by introducing common sense reforms to European pharmaceutical intellectual property rules.

Celecoxib generics could come sooner than expected

Generics/News | Posted 28/03/2014

Pharma giant Pfizer confirmed on 12 March 2014 that the United States District Court for East Virginia had invalidated its reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in its blockbuster anti-inflammatory painkiller Celebrex.

FDA increases oversight of drug safety in India

Generics/General | Posted 21/03/2014

The US Food and Drug Administration (FDA) has created an Office of Pharmaceutical Quality in response to quality concerns at home and abroad, particularly surrounding generic medicines from several Indian manufacturing plants [1].

Indian generics makers face US recalls

Generics/News | Posted 21/03/2014

Indian generics makers are once again coming under US Food and Drug Administration (FDA) scrutiny.

Generics contribution to availability of essential medicines

Generics/Research | Posted 14/03/2014

The creation of Essential Medicines Lists (EMLs) within country healthcare systems is promoted by the World Health Organization (WHO) in order to improve the availability and use of medicines considered essential.

Brand-name drugs also cut healthcare costs

Generics/General | Posted 14/03/2014

Generics are often given all the praise when it comes to cutting costs for patients and payers, but, according to a piece in Forbes, brand-name drugs also cut healthcare costs.

FDA approves generic osteoporosis drug

Generics/News | Posted 14/03/2014

FDA announced on 4 March 2014 that it had approved Teva Pharmaceutical Industries (Teva’s) generic version of Eli Lilly’s osteoporosis drug Evista (raloxifene).

Use of generic cardiovascular drugs in China

Generics/Research | Posted 07/03/2014

China has not yet recognized the importance of increasing generics use as a method to reduce drug prices. An analysis of drug prices in hospitals in the Chongqing province in China has shown that there are potentially major savings to be made by increasing the volume of generics used in China [1].

Teva and Ranbaxy settle unlawful competition investigation

Generics/News | Posted 07/03/2014

New York Attorney General Eric Schneiderman announced on 19 February 2014 that he had reached a settlement with generics makers Ranbaxy Pharmaceuticals (Ranbaxy) and Teva Pharmaceuticals (Teva) for entering into an anti-competitive arrangement.

Compliance and persistence same for generic and brand-name alendronate

Generics/Research | Posted 28/02/2014

A retrospective analysis of data in Italy has shown that patients taking generic and brand-name alendronate showed the same rates of persistence and compliance [1].

FDA starts widespread testing of generics

Generics/General | Posted 28/02/2014

The US Food and Drug Administration (FDA) has allocated US$20 million for testing generics and has already been assessing generics since September 2013, despite no announcement having been made.

Confusion exists in Brazil over generics

Generics/Research | Posted 21/02/2014

Brazilians are confused about generics and are unable to distinguish between a generic drug and a brand-name drug [1].

Gilead to license hepatitis C drug to Indian generics firms

Generics/News | Posted 21/02/2014

Gilead Sciences (Gilead) has announced plans to license its breakthrough hepatitis C drug Sovaldi (sofosbuvir) to at least three Indian generics manufacturers. The announcement made in February 2014, comes three months after the company faced a ‘patent opposition’ filed at India’s Patent Office, which aimed to block them from gaining a patent for Sovaldi in India.

Sandoz gains Belgian approval for generic inhalation device

Generics/News | Posted 14/02/2014

In an example of the innovative nature of generics manufacturers, Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 12 February 2014 that it had received marketing authorization in Belgium for AirFluSal Forspiro, an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD).