OTC ANDA approvals
This article was originally published in The Tan Sheet
Wockhardt receives FDA approval for a generic version of Pfizer's H2 blocker Zantac (ranitidine) in a 75 mg OTC dose, the Mumbai, India-based pharmaceutical and biotech firm reports Feb. 27. The firm's U.S. branch expects to launch the drug "shortly." Wockhardt already has made 150 mg and 300 mg prescription doses of the H2 available in the U.S. "With the addition of the OTC version, we will now have the full range of ranitidine medications in the U.S.," Executive Director Lalit Kumar states. Separately, FDA approved an ANDA for loratadine 10 mg (equivalent to Schering-Plough's Claritin) for Canadian firm Apotex on Feb. 22, the agency reports...
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