Ortho-McNeil’s levofloxacin (Levaquin) tablets and injection are now approved for the treatment of penicillin-resistant Streptococcus pneumoniae in community acquired pneumonia (CAP). Levofloxacin is already approved for the treatment of …
FDA’s May 28-June 1, 2001, inspection of API make Northeast General Pharmaceutical Factory of Shenyang, China, netted the maker of bulk sucralfate U.S.P. four citations on the Oct. 2 warning letter for stability records and calibration lapses. The Division of Manufacturing & Product Quality at the Center for Drugs informed the firm that CDER would recommend withholding approval of NDAs listing Northeast’s product as a component.
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Alpharma launches …
Alpharma USPD has launched Sucralfate Suspension in 1g/10 mL unit dose cups. Equivalent to the active ingredient in Aventis’ Carafate Suspension, Sucralfate Suspension will be marketed in a 50-cup case uncer the Xactdose label. Sucralfate Suspension is indicated for the short-term (up to eight weeks) treatment of active duodenal ulcer and will compete in the $4.3 million Sucralfate Suspension unit dose market. …
