Xiaflex®

XIAFLEX (collagenase clostridium histolyticum) is a combination of bacterial collagenases indicated for the treatment of: Adult patients with Dupuytren’s contracture with a palpable cord; Adult men with Peyronie’s disease with a palpable plaque and...

Santyl®

SANTYL (collagenase) Ointment is indicated for debriding chronic dermal ulcers and severely burned areas.

Enflonsia

ENFLONSIA (clerovimab-cfor) is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season.

Pombiliti

POMBILITI (cipaglucosidase alfa-atga) is a hydrolytic lysosomal glycogen-specific enzyme indicated, in combination with Opfolda, an enzyme stabilizer, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency)...

Erbitux®

ERBITUX (cetuximab) is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer: Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy; Recurrent locoregional...

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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