Generics/News
Watson buys women’s health company Uteron
Generics giant Watson Pharmaceuticals, now known as Actavis, announced on 23 January 2013 that it has completed the acquisition of Belgium-based Uteron Pharma for US$150 million in cash up front, and up to US$155 million in potential future milestone payments.
First generic versions of Duetact and Maxalt approved
First-to-file generics from Mylan and Sandoz have been approved by FDA for rizatriptan benzoate and pioglitazone hydrochloride/glimepiride tablets, respectively.
Watson becomes Actavis
Watson Pharmaceuticals announced on 24 January 2013 that the company had officially adopted Actavis as its new global name under which it will now trade on the New York Stock Exchange.
Pharmascience and Kolmar to create Korean generics joint venture
Canadian generics maker Pharmascience and Korea-based Kolmar Holdings (Kolmar) announced on 2 January 2013 that they had entered into an agreement to create a new joint venture, Pharmascience Korea, for the marketing of Canadian-made bioequivalent medicines.
Watson submits ANDA for generic cancer drug
Watson Pharmaceuticals confirmed on 28 December 2012 that Actavis, which was acquired by Watson in October 2012, has filed an Abbreviated New Drug Application (ANDA) with FDA seeking approval to market generic bortezomib. Actavis’ ANDA product is a generic version of Millennium Pharmaceuticals’ (Millennium) cancer drug Velcade (bortezomib).
Ranbaxy not the only Indian generics maker subject to FDA recalls
It seems that Ranbaxy Pharmaceuticals (Ranbaxy) is not the only Indian generics manufacturer who has been subjected to FDA recalls. It now comes to light that Dr Reddy’s Laboratories (Dr Reddy’s) and Aurobindo Pharma (Aurobindo) have also had to recall key generic drugs during 2012.
Ranbaxy recalls generic atorvastatin in US
Ranbaxy Pharmaceuticals (Ranbaxy) has fallen foul of FDA once again. The Indian generics major announced on its US website that it is conducting a voluntary recall for certain batches of its atorvastatin calcium tablets, a generic version of Pfizer’s blockbuster cholesterol-reducing drug Lipitor.
Generics competition for Pfizer’s sildenafil
Apotex Corporation, Dr Reddy’s Laboratories, Mylan, Torrent Pharmaceuticals and Watson Laboratories have all received FDA approval for bioequivalent generic versions of Pfizer’s Revatio (sildenafil citrate – Viagra in Europe) in the US market following the approval by FDA of the generics companies abbreviated new drug applications (ANDAs) for sildenafil tablets.
German court rules Seroquel XR patent invalid
AstraZeneca has lost another battle to protect its blockbuster anti-psychotic drug Seroquel (quetiapine fumarate) against generics.
FDA ordered to let Watson sell generic Actos
Watson Pharmaceuticals (Watson) has finally won its legal battle to be able to sell a generic version of Takeda Pharmaceutical’s diabetes drug Actos (pioglitazone hydrochloride). A US judge ordered FDA to approve Watson’s generic pioglitazone against the agency’s decision to bar Watson during the first six months of generics availability.
