10mg, 20mg ext-rel tabs 5 Adults and Children: May use ER tabs in place of IR tabs when the 8hr dose of methylphenidate ER corresponds to the titrated 8hr dose of methylphenidate IR. Max 60mg/day ...

Consequently, the FDA reclassified Mallinckrodt’s abbreviated New Drug Application (ANDA) 202608 for methylphenidate ER tablets with dosage strengths of 27 mg, 36 mg and 54 mg from AB (freely ...

PHILADELPHIA, May 29, 2019 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has commenced marketing Methylphenidate Hydrochloride Extended Release (ER) tablets USP (CII ...

QuilliChew ER, a CII controlled substance, will be available as 20mg scored, 30mg scored, and 40mg unscored chewable tablets in 100-count bottles. It is expected to launch in the first quarter of ...

* Durect Corp - ‍for primary efficacy endpoint, Oradur-Methylphenidate ER capsule was superior to placebo in a statistically significant manner * Durect - announced Orient Pharma has informed co ...

The agency wants to pull its approval; the company wants to know more about why. The Food and Drug Administration has decided to give Lannett Co. Inc. more time to show why its generic ADHD drug ...

BRIDGEWATER, N.J., Feb. 5, 2018 /PRNewswire/ -- Amneal Pharmaceuticals has launched methylphenidate hydrochloride extended-release tablets, USP (CII) in 18, 27, 36, and 54 mg strengths. Amneal's ...

* Lannett company inc- FDA agreed to delay submission deadline for Methylphenidate ER tablets * Lannett company-FDA suspended deadline to submit materials in support of its request for hearing to ...

Mallinckrodt's Specialty Brands revenue during fiscal 2Q16 rose to amount $535 million, translating to a 60% revenue jump YoY (year-over-year).

Generic methylphenidate hydrochloride extended-release products are intended to release drug into the body during a period of 10 to 12 hours. This should make feasible a single-dose product the ...

For the primary efficacy endpoint, ORADUR-Methylphenidate ER Capsule was superior to placebo in a statistically significant manner (p=0.0044 for the intent to treat population and p=0.0032 for the ...