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COV Rolls Out More Concerta Drugs

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Mallinckrodt, the Pharmaceuticals business of Covidien plc , launched more dosages of the Concerta (methylphenidate HCl) Extended-Release (ER) Tablets USP (CII). The company introduced the new 36 mg and 54 mg dosage strengths.

In Dec 2012, Covidien had won the U.S. Food and Drug Administration (FDA) approval to manufacture and sell a Concerta drug in 27 mg, 36 mg and 54 mg dosage strengths. Following the approval, the company immediately rolled out the 27 mg dosage and as per its plan introduced the other two in this quarter. Management believes that it holds a six-month exclusivity period for each of the respective dosage strengths following its commercial launch.

The tablets are used to treat patients, aged between 6 and 65, suffering from Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a neurobehavioral disorder, usually diagnosed in childhood. Children with ADHD are inattentive, hyperactive and impulsive. Despite being a long-term chronic condition, it can be successfully treated with proper therapy and medication. According to The American Psychiatric Association, roughly 3%–7% of school children have ADHD.

Mallinckrodt is a leading manufacturer of bulk acetaminophen in the world and the largest supplier of opioid pain management drugs in the U.S. It also features in the top 10 list of prescription-based generic pharmaceuticals manufacturers in the U.S. Covidien intends to divest Mallinckrodt by mid-2013 in an effort to focus on its high-margin surgical product portfolio.

Covidien had raised its full year guidance partially based on the successful FDA approval of the generic Concerta product in Dec 2012. The Pharmaceuticals division is anticipated to grow at a high single-digit rate or more (earlier 1% to 4%) in fiscal 2013. However, the company’s pharmaceuticals product line faces stiff competition from companies such as Johnson & Johnson (JNJ - Free Report) and Pfizer Inc. (PFE - Free Report) .

Covidien reached a 52-week high of $67.98 on Thursday, Mar 28, 2013. It currently has a Zacks Rank #2 (Buy). Other companies like Hanger Inc. , carrying a Zacks Rank #2 (Buy), are expected to do well in the medical industry.

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