Pfizer announces FDA acceptance of methylphenidate hydrochloride extended release chewable tablet NDA as ADHD treatment

FDA

Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for methylphenidate hydrochloride extended-release chewable tablet (methylphenidate hydrochloride ERCT). The product is being reviewed as a potential new treatment option for Attention Deficit/Hyperactivity Disorder (ADHD) in patients 6 years of age and older. The product was developed in conjunction with Tris Pharma, a manufacturing partner. The FDA Prescription Drug User Fee Act (PDUFA) date is December 4, 2015.

For more details, go to: http://www.streetinsider.com/Corporate+News/Pfizer+(PFE)+Announces+FDA+Acceptance+of+Methylphenidate+HCI+ERCT+NDA+as+ADHD+Treatment/10732074.html

Michael Wonder

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Michael Wonder

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