Generics
Tentative FDA approval for generic HIV treatment
FDA announced on 31 January 2012 that it had given tentative approval for generic versions of GlaxoSmithKline’s (GSK’s) blockbuster AIDs treatment Epzicom (abacavir sulfate and lamivudine). The tentative approval enables India-based generics companies Cipla and Mylan to sell their generics to US aid programmes, but not yet in the US.
Ranbaxy consent decree with FDA submitted to court
Ranbaxy Laboratories (Ranbaxy) announced on 26 January 2012 that the consent decree with FDA that was signed on 20 December 2011 has been filed with the United States District Court for the District of Maryland.
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.
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).
Generics market to experience strong growth in 2010–2017
The global market for generic drugs will experience strong growth in the coming years due to patent expiries of blockbuster drugs worth US$150 billion between 2010 and 2017. Cost containment strategies being implemented by governments and healthcare service providers are also given credit for shifting sales towards cheaper generics.
Watson expands in Asia with Ascent Pharmahealth
US generics manufacturer Watson Pharmaceuticals announced on 24 January 2012 that it had acquired Ascent Pharmahealth, the Australia and Southeast Asia generics subsidiary of Strides Arcolab, in a deal worth Australian dollars (A$) 375 million.
Factors important for generics substitution in Finland
What factors do patients take into account when deciding to accept or reject generics substitution? This is the question asked in a recent research article [1].
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).
