- Update: In 2018, Impax Laboratories merged with Amneal Pharmaceuticals LLC, to form Amneal Pharmaceuticals, Inc. Shares of newly public AMRX began trading on the NYSE on May 7, 2018.
*****
Concerta (Methylphenidate)
- Stimulant
- Brands: Concerta, Daytrana, Methylin, Ritalin, and Aptensio
- It can treat ADHD and narcolepsy.
Impax Labs announces AB therapeutic equivalent rating and final FDA approval on its Abbreviated New Drug Application for a generic version of Concerta :
Co has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration ("FDA") approval on its Abbreviated New Drug Application ("ANDA") for a generic version of Concerta (JNJ) Extended-Release tablets USP CII, 18, 27, 36 and 54 mg.
"We are preparing for launch including working to secure API quota and currently expect to launch by the end of this year. As a result, we don't anticipate sales of generic Concerta to meaningfully impact our earnings in 2017."
Methylphenidate hydrochloride extended-release tablets had U.S sales of ~$1.8 billion, according to IMS Health for the 12 months ending May 2017.
No comments:
Post a Comment