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FDA approves generic opiate-dependency drugs

On 22 February 2013, FDA approved two generic versions of the drug Suboxone (buprenorphine/naloxone), a treatment for recovering heroin addicts.

Ranbaxy restarts generic atorvastatin production

India-based generics giant Ranbaxy Laboratories (Ranbaxy) announced on 25 February 2013 that it has restarted production of its generic cholesterol lowering drug atorvastatin after solving contamination problems.

Pfizer asks US Court to reconsider generic Reglan ruling

Pfizer has asked the US Supreme Court of Alabama to reconsider its decision of 4 January 2013, which would allow generics patients to sue brand-name drugmakers.

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.

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