Drug Approval | November 22, 2021
Amneal gets approval for Difluprednate ophthalmic emulsion
The company is moving towards complex and more differentiated products
The company is moving towards complex and more differentiated products
It is the first U.S. FDA approved novel topical mechanism for acne in nearly 40 years
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
Results from year two of the pivotal Phase 3 KITE clinical trial reaffirmed visual acuity gains and fluid reduction findings as well as safety profile from year one
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