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Generics/News

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Generic and biosimilar user fee recommendations sent to Congress

Generics/News | Posted 03/02/2012

FDA has sent recommendations for user fee programmes, including those covering generic and biosimilar drugs, to US Congress. It is hoped that the fees will help speed up the delivery of safe and effective drugs to patients.

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Italy asked to comply with marketing rules for generics

Generics/News | Posted 03/02/2012

The news that the European Commission (EC) had finally issued a formal call on 26 January 2012 for Italy to comply with EU rules on the marketing authorisation of generic medicines was welcomed by the European Generic medicines Association (EGA) together with the Italian association for generic medicines (Assogenerici).

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Watson expands in Asia with Ascent Pharmahealth

Generics/News | Posted 27/01/2012

US generics manufacturer Watson Pharmaceuticals announced on 24 January 2012 that it had acquired Ascent Pharmahealth, the Australia and Southeast Asia generics subsidiary of Strides Arcolab, in a deal worth Australian dollars (A$) 375 million.

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Teva outlines expansion plans in Asia

Generics/News | Posted 20/01/2012

Generics giant Teva is looking for deals in Asia, which the company believes will see strong future expansion in the use of generics.

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Generic nasal spray approved by FDA

Generics/News | Posted 20/01/2012

India-based generics manufacturer Wockhardt announced on 10 January 2012 that it had received final approval from FDA for marketing a generic version of GlaxoSmithKline’s nasal spray allergy treatment Flonase (fluticasone).

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Teva gains tentative approval for generic atorvastatin

Generics/News | Posted 13/01/2012

Teva announced on 1 December 2011 that it had received tentative approval from FDA for its generic version of Pfizer’s blockbuster cholesterol-reducing medication Lipitor (atorvastatin).

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Pfizer continues to fight for Lipitor

Generics/News | Posted 16/12/2011

With the patent expiry of Pfizer’s blockbuster cholesterol-reducing drug Lipitor (atorvastatin) on 30 November 2011, Pfizer it seems is pulling out all the stops to delay generic erosion of its market share.

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Ranbaxy may settle with FDA for generic atorvastatin launch

Generics/News | Posted 16/12/2011

According to The Times of India, generics giant Ranbaxy Laboratories and FDA are getting closer to reaching an agreement to solve the Indian drugmaker’s regulatory troubles.

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Ranbaxy gets FDA approval and launches generic atorvastatin

Generics/News | Posted 02/12/2011

After all the speculation India-based Ranbaxy Laboratories (Ranbaxy) has resolved all outstanding issues and finally managed to gain approval from FDA for its generic version of the blockbuster cholesterol-reducing drug Lipitor (atorvastatin).