Drug Approval | June 10, 2022
Sanofi Dupixent gets USFDA nod for atopic dermatitis
Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood
Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood
Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)
Data from the three studies formed the basis of the company's application for approval by regulatory agencies
The Toradol tablets, 10 mg brand and generic had U.S. sales of approximately US $ 16.8 million MAT for the most recent twelve months ending in March 2022 according to IQVIA
Pfizer calls upon global health leaders and organizations to join the Accord, bringing their expertise and resources to close the health equity gap
Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to substantial burden and often disability among patients
Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date
Abevmy follows the launch of the company’s two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020
The icare4u program features a dedicated website, with comprehensive information about the diseases, videos with medical experts, and a social media community for patients and caregivers on Facebook and YouTube
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