FDA approval for generic diabetes drug Actos

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FDA approval for generic diabetes drug Actos

Generics/News | Posted 24/08/2012 0 Post your comment

On 17 August 2012, FDA gave final approval to Mylan Pharmaceuticals for the first generic version of Actos (pioglitazone hydrochloride tablets), for the treatment of type 2 diabetes. The approval covers tablets containing 15 mg, 30 mg and 45 mg pioglitazone.

Mylan, a global company with headquarters in Morgantown, West Virginia, USA, filed its first tentative Abbreviated New Drug Application for pioglitazone hydrochloride tablets back in November 2004.

The new generic drug is indicated alongside diet and exercise for the control of blood sugar levels in adult type 2 diabetics, which affects more than 26 million Americans, according to the Centres for Disease Control.

‘Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes,’ said Dr Gregory P Geba, MD, MPH, Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. ‘Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.’

In a press release, Mylan CEO Ms Heather Bresch commented: ‘Mylan's immediate launch of these products is representative of the company's ongoing commitment to expand access to high quality, more affordable medicines. A crucial part of setting new standards in health care includes meeting patients' unmet needs, and we look forward to continuing to grow our portfolio of products for patients living with diabetes.’

The originator drug Actos is produced by Takeda Pharmaceuticals, which, in December 2010, announced license agreements with Mylan, Ranbaxy Laboratories, Watson Pharmaceuticals and other generics manufacturers for the marketing of pioglitazone in the US, assuming market entry on 17 August 2012.

Based on this agreement, Ranbaxy Pharmaceuticals launched its generic version of pioglitazone hydrochloride tablets in the US market on 17 August 2012. Watson Pharmaceuticals, however, is now suing FDA for rejecting its application for shared exclusivity.

By end of May 2012, US sales of Actos had reached US$2.7 billion. However, there are health warnings associated with the use of Actos (and pioglitazone), owing to an increased risk of heart failure and bladder cancer. The most commonly reported side effects include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat.

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Source: FDA, IMS Health, PRNewswire, Thomson Reuters