Keeping Track: Pharming’s Joenja, Cidara’s Rezzayo And Incyte’s Zynyz Headline US FDA Approval Bonanza
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Melinta CEO and a representative of the Infectious Diseases Society of America call on a Senate HELP subcommittee to push for passage of PASTEUR Act. Introduced in the Senate and House for the third time this year, the measure would establish a subscription model to pay drug developers upfront for certain antimicrobials.
Court found FDA erred in finding Melinta received notice of Paragraph IV certification for generic Minocin on date specified by Nexus. Agency will not require Nexus to send a new notice or give Melinta heads up of final approval of the ANDA.
Pfizer’s InnoPharma unit finally overcame US FDA’s concerns about injectable acetaminophen GMPs and leachables. Meanwhile, Azurity resolved zonisamide manufacturing issues, Amphastar overcame doubts about naloxone’s nasal spray device, Incyte reused Zynyz CMC data, Cidara showed Rezzayo vials had enough powder, Pharming showed equivalence between Joenja tablets and capsules, and Orphalan avoided half-tablet stability testing of its functionally scored Cuvrior tablets.