APP gets FDA ANDA OK for ceftriaxone
American Pharmaceutical Partners says that it has received two approvals from the US Food and Drug Administration for its Abbreviated New Drug Applications for ceftriaxone for injection, USP, with the FDA's clearance of the issues surrounding the raw material supplier for this product.
APP received approvals for five product codes for ceftriaxone, the generic equivalent of Roche's Rocephin, including single dose and pharmacy bulk pack. According to IMS, ceftriaxone is the number one third-generation cephalosporin in both dollar sales and units sold. Total annual turnover of the drug in 2005 exceeded $570.0 million. APP says it will commence marketing immediately.
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