News
Italy asked to comply with marketing rules for generics
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).
Generic and biosimilar user fee recommendations sent to Congress
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.
Watson expands in Asia with Ascent Pharmahealth
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.
Teva outlines expansion plans in Asia
Generics giant Teva is looking for deals in Asia, which the company believes will see strong future expansion in the use of generics.
Generic nasal spray approved by FDA
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).
Teva gains tentative approval for generic atorvastatin
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).
Pfizer continues to fight for Lipitor
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.
Ranbaxy may settle with FDA for generic atorvastatin launch
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.
Ranbaxy gets FDA approval and launches generic atorvastatin
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).
Advocates demand generic version of Abbott’s HIV drug Kaletra
FDA watchdog Public Citizen, along with public health groups in a dozen countries, has launched a global campaign demanding the authorisation of generics competition for Abbott Laboratories’ HIV drug Kaletra (lopinavir/ritonavir) before its exclusivity expires.