Essex Nippon K.K., the company's Japanese subsidiary began marketing of the new aminoglycoside antibiotic in Japan. Isepacin (isepamicin) is approved, in Japan, in both IV and injection form for urinary and respiratory tract infections. Isepacin, which was discovered by Schering Research, will be co-marketed by the joint developers of the drug - Essex Nippon and Toyo Jozo, Ltd. Schering-Plough notes that the drug's safety profile has been established in clinicals of more than 1,000 patients. Isepacin is in clinicals in the U.S.
You may also be interested in...
A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.
Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals.
Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.