Generics/News

Generic rosuvastatin approved in Canada

Generics/News | Posted 23/03/2012

Generics giant Mylan Pharmaceuticals (Mylan) announced on 15 March 2012 that it had received approval from Health Canada for a generic version of AstraZeneca’s leading cholesterol drug Crestor (rosuvastatin). The approval covers tablets in 5, 10, 20 and 40 mg strengths.

First generic atorvastatin launched in Australia and Europe

Generics/News | Posted 16/03/2012

On 6 March 2012, Ranbaxy announced that it had obtained, pursuant to a settlement agreement with Pfizer, the rights to an early entry of its generic atorvastatin in Germany, Italy, The Netherlands and Sweden.

Hospira re-joins Generic Pharmaceutical Association

Generics/News | Posted 02/03/2012

Hospira announced on 23 February 2012 that the company had re-joined the Generic Pharmaceutical Association (GPhA). Hospira, self-proclaimed leader in injectable generics, added that it is dedicated to ‘advancing wellness’, a goal that matches well with the GPhA’s core purpose of bringing affordable medications to patients who need them.

Apotex clopidogrel at-risk launch costs US$442 million

Generics/News | Posted 02/03/2012

Sanofi and Bristol-Myers Squibb (BMS) announced on 8 February 2012 that generic drugmaker Apotex had paid a whopping US$442 million in damages in the Plavix (clopidogrel bisulfate) patent infringement case against Apotex.

Sun comes under fire from Pfizer

Generics/News | Posted 24/02/2012

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

Generics/News | Posted 17/02/2012

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

Generics/News | Posted 17/02/2012

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

Generics/News | Posted 10/02/2012

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

Generics/News | Posted 10/02/2012

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

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.

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).