Generics/News
Sun comes under fire from Pfizer
Sun Pharmaceutical Industries (Sun Pharma) is coming under fire from Pfizer, as the generics major is sued for violating patents on Pfizer’s Protonix (pantoprazole).
Watson files ANDA for generic Beyaz
Watson Pharmaceuticals (Watson) announced on 10 February 2012 that it had filed an Abbreviated New Drug Application (ANDA) with FDA for a generic version of Bayer HealthCare’s (Bayer) leading oral contraceptive Beyaz (drospirenone/ethinyl estradiol/levomefolate).
Sandoz submits ANDA for generic treprostinil
US drugmaker United Therapeutics announced on 6 February 2012 that it had received a Paragraph IV Certification Notice Letter from Sandoz, the generics division of Swiss-based drug giant Novartis. The notice letter stated that Sandoz had submitted an Abbreviated New Drug Application (ANDA) to FDA requesting approval to market a generic version of the 10 mg/mL strength of Remodulin (treprostinil) injection.
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).
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).
