The company said the Metaxalone Tablets USP, 800 mg is the therapeutic equivalent to the reference listed drug, Skelaxin of King Pharmaceuticals Inc.
For the 12 months ended September 2016, the total US sales of Metaxalone Tablets USP, 800 mg, at Average Wholesale Price (AWP) were about USD173m, according to IMS.
CEO Arthur Bedrosian stated that Metaxalone Tablets is indicated as an adjunct to rest, physical therapy and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions.
Buehler, supra note 40, at 1 ("[T]he FDA has determined that labeling corresponding to the use (U-189) listed in [the Orange Book] for [the listed '128 patent] may be carved out of the metaxalone labeling.
at 4 (finding that the omission of food effect labeling will not render use of metaxalone less safe or effective).
18, 2004) (de scribing why deletion of the bioavailability information would render metaxalone less sate and effective).
iCeutica'), a rapidly growing pharmaceutical company focused on creating new and improved drugs for patients, today announces that it has commenced the clinical program for Metaxalone SoluMatrix[TM] tablets.
iCeutica's investigational Metaxalone SoluMatrix[TM] tablets are a reformulation of the popular muscle relaxant sold by King Pharmaceuticals[R] (owned by Pfizer[R]) as Skelaxin[R].
iCeutica plans to compare its metaxalone reformulation with a cyclobenzaprine hydrochloride muscle relaxant product, which is the dominant molecule prescribed in the muscle relaxant class.
iCeutica has been able to successfully reformulate metaxalone by utilizing its proprietary SoluMatrix[TM] technology, which reduces the particle size of the active drug by more than 100-fold.
We are very pleased to commence the clinical program for Metaxalone SoluMatrix[TM]," iCeutica CEO Matt Callahan commented.
These products include metaxalone
400-mg tablets (Skelaxin); tramadol hydrochloride (HCL) and acetaminophen tablets (Ultracet); ondansetron HCl orally disintegrating tablets (Zofran ODT); and mirtazapine orally disintegrating 45-mg tablets (RemeronSolTab).