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Generics

News

Glenmark gains FDA approval for MS and pneumonia generics posted 07/12/2018

In November 2018, Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced the approval of generics for the treatm...

Apotex having trouble with Competitive Generic Therapy exclusivity posted 23/11/2018

In August 2018, the US Food and Drug Administration (FDA) approved its first drugs under the Competitive Generic Therapy (CGT...

Generics companies winning the legal battle in the US posted 19/11/2018

Litigation in the US is clearing the way for generics competitors to enter the market. The latest cases include Spring Pharma...

China approves first ambrisentan generic posted 19/11/2018

China’s drug regulator, the China Food and Drug Administration (CFDA, 国家食品药品监督管理局 in simplified Chinese), has approved its fi...

Teva launches generic tadalafil but delays launch of generic Suboxone posted 19/10/2018

Teva Pharmaceutical Industries (Teva) announced in September 2018 that it was launching generic tadalafil but would be delayi...

 

Research

Effectiveness of chronic hepatitis C treatment using direct-acting antivirals: real-life data posted 30/11/2018

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

Higher generics use results in higher Medicare Part D star ratings posted 16/11/2018

A study conducted by researchers from Auburn University and IMPAQ International has found that Medicare# Part D* prescription...

Ensuring a stable supply of APIs in Japan posted 09/11/2018

A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical p...

Individual pathways for development of complex generics posted 02/11/2018

The downside of having clear regulatory standards for approval of pharmaceuticals, according to Rodrigo Cristofoletti from Br...

Platelet reactivity with generic and brand-name clopidogrel posted 19/10/2018

The salt linked to the clopidogrel molecule in generic preparations is suspected to affect its clinical efficacy. However, th...

 

General

Way cleared in US for Suboxone and Zytiga generics posted 07/12/2018

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...

Teva sues FDA for changing ‘first applicant’ definition for generics posted 09/11/2018

There is yet another twist in the tale of generics of Allergan’s blockbuster dry eye treatment, Restasis (cyclosporine ophtha...

FDA proposes standardization of generics standards posted 02/11/2018

The US Food and Drug Administration (FDA) announced on 18 October 2018 that it has proposed to the International Council on H...