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news.Mylan has launched a generic version of Janssen's Concerta tablets in the US, after receiving approval from the local authorities.
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The Pennsylvania based global pharma rolled out Methylphenidate Hydrochloride extended-release tablets USP, 18mg, 27mg, 36mg and 54mg, which are indicted for treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The company has obtained final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for the product.
Mylan CEO Heather Bresch said: "The launch of generic Concerta Tablets demonstrates Mylan's leadership in complex development and manufacturing and in bringing to market a broad portfolio of high quality generics. This launch also further strengthens our robust portfolio of central nervous system medications, which is the largest in the US with more than 100 products.”
According to IMS Health, Methylphenidate Hydrochloride Extended-Release Tablets USP, 18 mg, 27 mg, 36 mg and 54 mg had recorded sales of nearly $1.59bn in the US for the 12 months ending 31 October 2016.
Mylan stated that the Methylphenidate HCl ER Tablets USP should be administered with care to patients having a history of dependence on either drugs or alcoholism.
As of now, the American pharma company citing IMS Health, claims to have over 240 ANDAs pending FDA approval representing around $95.6bn in annual brand sales.
Apart from the ADHD tablets, Mylan has also launched generic Cerebyx Injection and generic Zovia tablets in the US this week.
Image: Mylan has launched Methylphenidate Hydrochloride Extended-Release Tablets USP in the US to treat ADHD. Photo: courtesy of Stuart Miles/Freedigitalphotos.net.