Actavis seeks FDA approval to market generic Opana ER Watson Pharmaceuticals.

Food and Drug Administration seeking approval to advertise Oxymorphone Hydrochloride Extended-launch Tablets. Related StoriesKolltan announces presentation of data from KTN0158 preclinical study in mast cell tumors at ESMO 2015Allergan settles patent litigation with Amneal related to NAMENDA XR prolonged release capsulesFDA accepts Chiasma's NDA filing for octreotide capsules for treatment of adult patients with acromegaly On January 18 Endo and Grunenthal GmbH filed suit against Actavis, 2013, in the U.S.Goldfeder, C.C.R.P., Eunhwa Kang, M.Sc., Boyoung Jin, R.N., Hyeeun Park, R.N., Hyunkyung Kwak, B.S., Hyunchul Kim, Ph.D., Han-Seung Jeon, M.S., Ina Jeong, M.D., Joon Sung Joh, M.D., Ray Y. Chen, M.D., Kenneth N. Olivier, M.D., Pamela A. Shaw, Ph.D., Dean Follmann, Ph.D., Sun Dae Tune, M.D., Ph.D., Jong-Koo Lee, M.D., Dukhyoung Lee, M.D., Cheon Tae Kim, M.D., Veronique Dartois, Ph.D., Seung-Kyu Park, M.D., Sang-Nae Cho, D.V.M., Ph.D., and Clifton E. Barry, III, Ph.D.: Linezolid for Treatment of Chronic Extensively Drug-Resistant Tuberculosis Linezolid was authorized in 2000 for drug-resistant, gram-positive bacterial infections.1 A known member of the oxazolidinone antibiotic class, linezolid inhibits protein synthesis by binding the 23S ribosomal RNA part of the bacterial 50S ribosomal subunit.2 In adults, linezolid is administered at a dose of 600 mg twice daily, with phase 3 and postmarketing trials showing an acceptable side-effect and adverse-event profile during the FDA-approved 28 days of therapy.3 Data on longer-term use are limited, but serious neuropathies , myelosuppression, and hyperlactatemia have been observed4,5 and are considered to be linked to the inhibition of mitochondrial protein synthesis.8-11 It has only modest activity in murine types of tuberculosis.12,13 A study of the first and extended bactericidal activity of linezolid showed only minimal early activity and no late activity , with the authors concluding that linezolid had small tissue-sterilizing ability and therefore had a limited role in the treatment of MDR tuberculosis.14 Despite these characteristics, numerous case reports and retrospective studies claim that linezolid may be effective in treating MDR and XDR tuberculosis.15-21 These scholarly studies all have essential limitations, including a retrospective design, small numbers, the use of linezolid with multiple additional active agents, no controls, and limited follow-up.