US-based pharmaceuticals company Mylan has launched the Methylphenidate Hydrochloride Extended-Release Tablets USP in the country for the treatment of patients affected with attention deficit hyperactivity disorder (ADHD).
ADHD is a mental disorder of the neurodevelopmental type. Patients affected face several issues such as paying proper attention, excessive activity, or difficulty controlling a type of behaviour that is inappropriate for a person's age.
The 18mg, 27mg, 36mg and 54mg tablets are a generic version of Belgium-based pharmaceutical company Janssen's Concerta Tablets.
Mylan chief executive officer 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.
“We're excited about bringing another generic in this therapeutic area to market and expanding access to help patients.”
Mylan has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for the product.
According to US-based information technology company IMS Health, Methylphenidate Hydrochloride Extended-Release Tablets USP recorded US sales of nearly $1.59bn over the 12 months ending 31 October 2016.
The tablets should be administered cautiously to patients with a history of drug dependence or alcoholism.
Chronic abusive use can cause significant tolerance and psychological dependence with a wide range of abnormal behaviour.
On 28 December last year, Mylan launched the Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1mg / 0.05mg, to be used by women to prevent pregnancy.