The company said Exalgo 32mg
extended release tablets (hydromorphone HCl) is an opioid agonist indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
ViramuneEeA increased mean absolute HDL-c from baseline (13.4 mg/dL for ViramuneEeA IR and 11 mg/dL for nevirapine
extended release formulation (ViramuneEeA XR)).
ANDAs are being submitted to obtain regulatory approval to market these
extended release versions, and this is resulting in some high profile patent infringement lawsuits.
Previously, IMPAX Laboratories announced that the FDA had accepted the company's ANDAs for generic versions of Claritin- D 24-Hour (loratadine/ pseudoephedrine sulfate)
Extended Release Tablets and Claritin(R) Reditabs (loratadine) Orally Disintegrating Tablets.
Astellas was granted marketing approval for tacrolimus
extended release capsules under the trade name Advagraf in Europe in 2007 and under the trade name Graceptor inJapan in 2008.
Specialty pharmaceutical company Impax Laboratories (NasdaqGS:IPXL) disclosed on Thursday the availability of the generic version of Kadian (morphine sulfate)
Extended Release Capsules, USP CII 20, 30, 50, 60, 80, 100 mg.
Pharmaceutical products company Lannett Company (NYSE:LCI) disclosed on Monday the receipt of approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Paroxetine
Extended Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg in the market.
Novel therapies company Relmada Therapeutics (Other OTC:RLMD) reported on Wednesday that it has been granted a patent (EP 2 448 406 B1) from the European Patent Office (EPO) for compositions and methods of use for its
extended release oral levorphanol (3-hydroxy-N-methylmorphinan).
M2 EQUITYBITES-December 1, 2015-Eisai and Arena Pharmaceuticals' NDA for
extended release formulation of lorcaserin accepted by US FDA for chronic weight management
M2 PHARMA-December 1, 2015-Eisai and Arena Pharmaceuticals' NDA for
extended release formulation of lorcaserin accepted by US FDA for chronic weight management