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.
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).
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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.
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.
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.
Drug Discovery World
MARCH 29, 2023
Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. However, stakeholders should be aware that the leaked review contains no such analysis.
Pharma in Brief
JANUARY 9, 2022
In 2020, the FC struck down the new price calculation contained in the amendments but upheld the other impugned amendments. The proposed amendments contain fee changes including the introduction of an excess claim fee for applications with over 20 claims. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.
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