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Marsam tobramycin

Executive Summary

ANDA for the injectable product approved by FDA on Aug. 9. An aminoglycoside antibiotic used to treat infections of the lower respiratory tract, central nervous system and abdomen, the drug is a generic version of Lilly's Nebcin. Marsam received approval for 10 mg/ml and 40 mg/ml solution packaged in 1.5 ml and 2 ml syringes. The products will be marketed by Squibb's SquibbMark division under the Squibb-Marsam label following the expiration of Lilly's patent on Sept. 12. One week earlier, FDA approved non-sterile bulk version of tobramycin produced by Pharmachim Economic Corp. of Bulgaria.
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PS016108

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