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Generics

News

FDA approves generics from Amneal and Dr Reddy’s, and Natco submits ANDA posted 22/03/2019

In January 2019, the US Food and Drug Administration (FDA) approved Amneal Pharmaceutical’s (Amneal) generic Exelon patch and...

Mylan launches Advair generic at 70% discount posted 04/03/2019

US-based drugmaker Mylan announced on 12 February 2019 the launch of Wixela Inhub (fluticasone/salmeterol inhalation powder,...

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...

 

Research

Factors associated with increased side effects and lower perceived efficacy when switching to a generic posted 22/03/2019

In 2017, the New Zealand Pharmaceutical Management Agency (PHARMAC) changed the funded version of the antidepressant venlafax...

Escalating prices of generic drugs in the US posted 18/03/2019

Generic prescription drug prices have been escalating rapidly in the US. In 2014, generic drug prices increased by 38% on ave...

The 700-dollar vitamin: excessive generics prices in the US posted 01/03/2019

Authors from Johns Hopkins University School of Medicine discuss excessive prices for generics in the US, using vitamin K1 as...

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...

 

General

Pilot procurement scheme in China cuts drug prices posted 08/03/2019

The Chinese pharmaceutical market, which is dominated by domestic manufacturers, is the second largest in the world in terms...

USP action plan for generics and FDA new innovation office posted 04/03/2019

The US Pharmacopeia (USP) has issued an action plan to promote generics and the US Food and Drug Administration (FDA) has ann...

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...