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News

China approves first ambrisentan generic posted 26/10/2018

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...

European approval for fluticasone/salmeterol and gefitinib generics posted 19/10/2018

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 10 September 2018 that its subsidiary Glenmark Arzneim...

FDA approves first EpiPen generic amid shortages posted 28/09/2018

The US Food and Drug Administration (FDA) announced on 16 August 2018 that it had approved the first generic version of EpiPe...

Australia approves first capsule-form Viagra generic posted 14/09/2018

Singapore-based iX Biopharma announced on 6 August 2018 that it had received approval from Australia’s Therapeutic Goods Admi...

 

Research

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...

Free prescriptions do not always increase use of generics posted 19/10/2018

One strategy to increase the use of generics is to offer them free of charge. This strategy presumes that this will shift dem...

AA010968 Limited distribution networks found to be anticompetitive posted 05/10/2018

Limited distribution networks, whereby a drug manufacturer has a contract with one or a small number of distributors, suppres...

 

General

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...

FDA approves first drug via Competitive Generic Therapy pathway posted 12/10/2018

The US Food and Drug Administration (FDA) announced on 8 August 2018 that it had approved its first drugs under the Competiti...

Hospitals launch non-profit generics company posted 05/10/2018

Several major hospital groups announced the official launch of their non-profit generics company, Civica Rx, on 6 September 2...

Novartis divests dermatology and generic oral solids portfolios and part ways with Alcon posted 25/09/2018

Swiss drugmaker Novartis is to divest the Sandoz US dermatology business and generic US oral solids portfolio to Aurobindo an...