Containment Generic Drugs Packaging 
Drug Patent Watch
MARCH 12, 2025
The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? For generic drug manufacturers, stability testing is a critical step in the development process.
Camargo
OCTOBER 14, 2021
The sponsors of the accepted proposals will submit a full package consisting of required toxicology and quality data, as outlined in the Federal Register. Upon review of these packages, CDER will provide input on the acceptability of the excipient in the proposed use. Appellate Court Ruling Impacts Orphan Drug Exclusivity.
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Camargo
DECEMBER 9, 2020
The pharma industry has had meetings with the FDA for new drugs, biologics, and devices for decades. In stark contrast, meetings for ANDAs with the Generic Drug Division have been few and far between, inconsistently granted, and, if held, poorly documented. GDUFA has changed this picture, at least for complex drug products.
Pharmacy Checkers
MAY 22, 2020
The Januvia package reads “Formulated in UK.” The Januvia package also states “Sitagliptin (active ingred.) There are many thousands of drugs approved for the U.S. Janumet, a dual compound drug (two drugs – APIs – in one pill), contains the same API as Januvia, sitagliptin, and another API, metformin.
FDA Law Blog
AUGUST 17, 2023
Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § 355(j)(2)(A)(v).
XTalks
AUGUST 2, 2023
Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. 2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. It contains the antiviral medications nirmatrelvir and ritonavir. billion in 2022.
Pharma in Brief
AUGUST 9, 2021
Rolling submissions, which are currently in use for COVID-19 drugs, would be extended to other drugs, such as those which address significant new and emerging infectious diseases in Canada, or which treat, prevent, or diagnose serious or severely debilitating diseases or conditions. Biologic Drugs. On-site Evaluations.
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