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News

Zydus gets FDA approval for skin, heart and acid reflux generics posted 15/02/2019

Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market betamethasone dipropionate...

FDA approves Lupin’s generic clobazam and Dr Reddy's launches follow-on sevelamer carbonate posted 12/02/2019

By end of 2018, Lupin Pharmaceuticals Inc received US Food and Drug Administration (FDA) approval for its clobazam oral suspe...

Teva receives FDA approval for Sabril and launches Elidel cream posted 04/02/2019

In January 2019, Teva Pharmaceutical Industries (Teva) received US Food and Drug Administration (FDA) approval for its first...

Sun Pharma gets FDA approval for ganirelix acetate and plans to acquire Japan’s Pola Pharma posted 01/02/2019

Sun Pharmaceutical Industries (Sun Pharma), one of India’s largest pharmaceutical company, marks the start of 2019 with two e...

Dr Reddy’s launches omeprazole and continues sales of generic Suboxone in the US posted 01/02/2019

India-based generics manufacturer Dr Reddy’s is set to have a busy 2019 with the recent launch of generic omeprazole delayed-...

 

Research

European regulatory framework for approval of biosimilars – perspectives and future developments posted 19/02/2019

Regulatory agencies around the world have reviewed and approved marketing authorization applications for biosimilars via spec...

Safety surveillance of bevacizumab biosimilar (Bevax) in Argentina posted 18/02/2019

Benefit-risk evaluations are mandatory throughout the life cycle of a therapeutic agent, to guarantee efficacy for the author...

Impact of generic reference pricing on candesartan and rosuvastatin use in South Africa posted 15/02/2019

Researchers from South Africa and The Netherlands investigated the effect that generics and generic reference pricing has on...

Safety of brand-name and generic angiotensin II receptor blockers posted 01/02/2019

Authors of a study carried out in Canada found that there is still uncertainty regarding generics substitution of angiotensin...

Effectiveness of chronic hepatitis C treatment using direct-acting antivirals: real-life data posted 01/02/2019

Hepatitis is an inflammation of the liver and can be caused by medications, toxins, severe alcohol use and other medical cond...

 

General

Generics applications under review by EMA – January 2019 posted 04/02/2019

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the lo...

Non-profit generics maker expects first generics in 2019 posted 25/01/2019

Non-profit generics company, Civica Rx announced on 7 January 2019 that it expects to launch its first generics during 2019 a...

Way cleared in US for Suboxone and Zytiga generics posted 19/12/2018

The US Court of Appeals is clearing the way for generics competitors to enter the market. The court has lifted an injunction...

FDA approves more generics in 2018 than any other year posted 30/11/2018

The US Food and Drug Administration (FDA) approved 971 generics in 2018, more than in any previous year, according to the Act...

Brazil to remove backlog for generics posted 09/11/2018

Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) announced on 3 October 2018 that it w...