Generics
Sponsors thought a shorter goal date extension was appropriate if a facility received the unofficial potential Official Action Indicated tag, but the FDA said it needs the extra time to complete the final steps in the application review.
Ascent had hoped to join a growing list of US mirabegron competitors, but a Delaware court found its ANDA would infringe valid Astellas patents covering the sustained-release formulation.
As the US Supreme Court prepares to review litigation on generics with carved-out indications, or skinny-labels, Hikma once again won the the US solicitor general's support.
The FDA offered to relax the onshoring criteria to receive a priority ANDA review in GDUFA IV, but could drop another America First proposal.
During a candid and revealing discussion, lobbying experts shared strategies for getting the generics and biosimilars industry’s message heard by lawmakers.
Pink Sheet editors discuss the generic and biosimilars industries’ 2026 priorities as well as FDA Commissioner Martin Makary’s interesting take on the compassionate use program.
The US Supreme Court’s decision to review Hikma and Amarin’s litigation over induced infringement of carved-out patented indications offers a chance to resolve key questions around skinny-label generics, said attorney Chad Landmon.
The idea proposed by industry could be an attempt to increase first-cycle approvals and reduce overall review times, but the FDA has questions.
Moves to issue a compulsory license for Lilly’s GLP-1tirzepatide products Mounjaro and Zepbound come as Brazil prepares to make its own versions of Novo Nordisk’s semaglutide and liraglutide.
States allege Novartis and its former subsidiary Sandoz colluded with rivals to keep generic drug prices high, then restructured the Sandoz business to limit antitrust liability.
More than half of the drugs launched on TrumpRx are old Pfizer drugs the company acquired through the acquisitions of Warner-Lambert, Pharmacia or Wyeth.
The FDA proposed allowing sponsors that use domestic API suppliers and finished dosage form manufacturing and conduct BE testing in the US to receive a shorter ANDA review.
The FDA wants to waive facility fees for three years if a sponsor breaks ground on a US-based manufacturing plant, but industry is concerned the idea will force other sponsors to subsidize competition.
FDA officials want to charge the generic drug program fee per ANDA owned going forward, rather than the current practice of separating firms into different fee-paying tiers based on the number of ANDAs owned.
The latest step in the long-running saga of Hikma and Amarin’s induced infringement dispute over Vascepa is a US Supreme Court review of the litigation, which could result in changes to generic drug skinny-label policy.
Regulators in the US and Canada are working together to streamline approval timelines for generic drugs through a voluntary information sharing program.
“Section viii cannot function as Congress intended,” if a Federal Circuit Court ruling stands, the US solicitor general argued in urging the Supreme Court to review and reverse the closely-watched Hikma Vascepa skinny-label case.
The CDER Office of Generic Drugs published a MaPP for prescription-to-nonprescription switches to explain the regulatory responsibilities of generic sponsors.
The FDA told the Pink Sheet an ANDA managed to be submitted during a period when no new ANDAs could be accepted.
ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.