Generics/News
First generic celecoxib approved by FDA
The US Food and Drug Administration (FDA) announced on 30 May 2014 that it had approved the first generic versions of celecoxib capsules.
Sun Pharma’s Gujarat site under FDA import alert
Sun Pharmaceutical Industries’ (Sun Pharma) response to the US import ban on products produced at the company’s Gujarat site is inadequate, according to a warning letter issued by the US Food and Drug Administration (FDA) on 7 May 2014.
Novartis settles Gleevec lawsuit with Sun Pharma
Sun Pharmaceutical Industries (Sun Pharma) announced on 15 May 2014 that it had reached a settlement agreement with originator drug developer Novartis over litigation concerning generic Gleevec (imatinib mesylate).
FDA sued over generic celecoxib approval
Generics makers Actavis and Mylan Pharmaceuticals (Mylan) have sued the US Food and Drug Administration (FDA) over the agency’s decision to award exclusive rights to Teva Pharmaceutical Industries (Teva) to sell a generic version of Pfizer’s blockbuster anti-inflammatory painkiller Celebrex (celecoxib).
Taiwan TWi gains FDA approval for generic nifedipine
Taiwan’s TWi Pharmaceuticals (TWi) announced on 7 April 2014 the approval of its abbreviated new drug application (ANDA) for generic nifedipine by the US Food and Drug Administration (FDA).
Dr Reddy’s launches generic amlodipine/atorvastatin
Indian generics giant Dr Reddy’s announced on 27 March 2014 the launch of its generic amlodipine/atorvastatin tablets in the US.
Celecoxib generics could come sooner than expected
Pharma giant Pfizer confirmed on 12 March 2014 that the United States District Court for East Virginia had invalidated its reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in its blockbuster anti-inflammatory painkiller Celebrex.
Indian generics makers face US recalls
Indian generics makers are once again coming under US Food and Drug Administration (FDA) scrutiny.
FDA approves generic osteoporosis drug
FDA announced on 4 March 2014 that it had approved Teva Pharmaceutical Industries (Teva’s) generic version of Eli Lilly’s osteoporosis drug Evista (raloxifene).
Teva and Ranbaxy settle unlawful competition investigation
New York Attorney General Eric Schneiderman announced on 19 February 2014 that he had reached a settlement with generics makers Ranbaxy Pharmaceuticals (Ranbaxy) and Teva Pharmaceuticals (Teva) for entering into an anti-competitive arrangement.
