2010, FDA, Physicians and Prescription

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2010

FDA

Physicians

Prescription

Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

OCTOBER 25, 2022

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 Between 2010 and the end of 2015, of the 655 New Drug Applications (NDAs) approved by the FDA, 63 were for FDCs. Of those 131 approved FDCs, 98 were oral dosage forms.

Manufacturing

Manufacturing Physicians Prescription FDA

Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Biosimilars with this designation are beneficial to payers as they eliminate the need for another prescription, she explains An interchangeable biosimilar can be automatically substituted for Humira at a pharmacy, Bhat adds.

Marketing

Marketing Physicians Competition Patients

Pharma Rep Focus

Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Humira biosimilars set the stage for long-awaited 2023 US launches

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