News
FDA approves first generic ibandronate sodium osteoporosis drugs
FDA announced on 19 March 2012 the approval of the first generics of GlaxoSmithKline’s and Roche’s postmenopausal osteoporosis drug Boniva (ibandronate sodium).
AstraZeneca sues FDA over generic quetiapine
In an attempt to prevent competition from generics to its blockbuster anti-psychotic drug Seroquel (quetiapine fumarate), pharma giant AstraZeneca has filed a lawsuit against FDA.
Generic rosuvastatin approved in Canada
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
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
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
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
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.