Draft guidance on the approval pathway for competitive generic therapies (CGTs) has been published by the FDA in the agency’s latest move to advance generic drug competition.
The US Food and Drug Administration (FDA) has released a draft guidance on competitive generic therapies (CGTs) in the agency’s latest move to increase generic competition.
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After receiving a favorable court ruling last year, Lupin has secured its first-place spot for generic tolvaptan tablets in the US.
The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.
Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.
As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.
