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Not sure if you saw this news today
Lannett Says FDA Plans to Withdraw Approval of ANDA For ADHD Treatment
MT Newswires
07:41 AM EDT, 10/19/2016 (MT Newswires) -- Lannett Co. (LCI) said pre-market Wednesday that the Food and Drug Administration plans to withdraw approval of an abbreviated new drug application filed for Methylphenidate Hydrochloride extended-release tablets.
The HCl tablets are indicated for the treatment of attention deficit hyperactivity disorder.
In response to the FDA's notice, Lannett CEO Arthur Bedrosian said the company believes the tablets are safe and effective and that Lannett will review the FDA's scientific rationale for the decision and compile "scientific evidence to convince FDA's Office of Generic Products that our product should continue to be marketed."
Under the FDA's proposal, Lannett will have until Nov. 17 to request a hearing and until Dec. 19 to submit data upon which the request for a hearing relies.