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).
While muscle relaxants--carisoprodol, metaxalone
and others--may alleviate acute neck pain, they're not so effective for chronic pain, Dr.
And it has added Metaxalone
tablets, available in an 800 nag strength and a 100-count, that is AB-rated and therapeutically equivalent to Skelaxin (from King Pharmaceuticals Research and Development Inc.).
Recently launched products include buprenorphine HC1 and naloxone HCI dihydrate sublingual tablets, one of the first generic versions of Suboxone; potassium chloride extended-release capsules; and sildenafil, nevirapine, metaxalone
, and warfarin sodium --all in tablet form.
The launches of other key first-to-file products in the United States included metaxalone
(Skelaxin, King Pharmaceuticals Inc.) and amoxicillin-clavulunate potassium ER (Augmentin ER, GlaxoSmithKline PLC).
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).