The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

FDA Approval 52

FDA Approval Generic Drugs Production Drugs 52

The Pharma Data

APRIL 4, 2023

Recently, US Food and Drug Administration (FDA) also approved the citrate-free HCF of Hyrimoz ® (adalimumab-adaz) injection. 1 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL.

Medicine 40

Medicine Generic Pharmaceutical FDA Approval Marketing 40

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Frequent amendments (1998–2016). Patent listing eligibility.

Regulation 52

Regulation Compliance Medicine Manufacturing 52

XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir.

Sales 98

Sales Manufacturing FDA Approval Life Science 98