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Teva’s subsidiary Barr Laboratories agreed to pay $225 million to settle a class action lawsuit alleging it reached pay-for-delay settlements that postponed the launch of generic versions of Bayer’s antibiotic Cipro. Read More
The HHS secretary recently delivered FDA’s recommendations for reauthorizing user fees covering prescriptions, generic drugs and biosimilars to Congress, before the body begins to craft a legislation package due by the end of September. Read More
The World Trade Organization ratified an amendment to the Trade Related Aspects of Intellectual Property Rights (TRIP) agreement, authorizing developing countries with limited production capacity to import generics when facing a drug shortage. Read More
The Supreme Court has agreed to hear a case centered on whether a 180-day notification is mandatory or optional — when the appropriate disclosures are made — before a biosimilar launch. Read More
Generic drug applications surged in December, with the FDA receiving 235 ANDAs — the second-highest submission record for a particular month since the implementation of GDUFA. Read More
The FDA responded to commonly raised questions about the 180-day exclusivity for generics in a draft guidance document covering everything from patents to forfeitures. Read More
The FDA rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same nonproprietary names as their reference products, finding them incompatible with final guidance on the agency’s naming scheme published earlier this month. Read More
Manufacturers seeking approval for generic versions of drug-device combination products, such as prefilled syringes and auto-injectors, should strongly consider minimizing the differences between the generic’s user interface and that of the reference product, FDA advised in new draft guidance. Read More
The FDA will proceed with using a nonproprietary naming approach that relies on arbitrary four-letter suffixes to distinguish biosimilars and biologics, showing a disregard for industry concerns in a lightly tweaked final guidance that adds a few new considerations for suffix proposals. Read More