Lupin, Glenmark and Orchid receive FDA OK for levetiracetam
This article was originally published in Scrip
LupinPharmaceuticals, Glenmark Genericsand Orchid Chemicals and Pharmaceuticals, have received approval from the US FDA for levetiracetam 250mg, 500mg and 750mg tablets, generic versions of UCB Pharmaceuticals' anti-epileptic, Keppra tablets. Lupin has received approval for levetiracetam 1,000mg tablets and the company has begun commercial shipments of its products. Glenmark has commenced marketing and distribution of its generic versions in the US – it has a partnership with Invagen Pharmaceuticals for the product, under which Glenmark will exclusively market and distribute the product while Invagen is responsible for its manufacture and supply. Levetiracetam tablets had sales of about $1.2 billion in the 12 months ended September 2008. Glenmark now has 38 generic products authorised for distribution in the US, while Orchid's cumulative ANDA approval count now stands at 30.
You may also be interested in...
Takeda launches blockbuster gastrointestinal drug vedolizumab in India, stepping up the tempo on the back of the local base provided by its acquisition of Shire. More expansion in the country appears to be in store for the Japanese firm.
A new report on the preparedness of 10 APAC nations to tackle a mounting cancer burden identifies gaps that need to be addressed, saying that a focus on prevention and early diagnosis could help, while also touching on issues around regional drug availability.
Also, deals involving Sumitomo Dainippon, Tolero, Boston Biomedical, Zai Lab, Turning Point, SciClone, EpicentRx, Yuhan, GI Innovation, Takeda, Carmine, HitGen, Morphic, CStone and Burning Rock.