Generic Line

Due to summer holidays, Generic Line will not be published July 3. The next issue will be published July 17.

“Pay-for-delay” deals between brand drugmakers and their generic competitors can sometimes violate antitrust law, the Supreme Court ruled June 17, issuing a tempered decision that will make it easier for legal challenges to be brought by critics of the practice.

An industry effort to protect user fees from sequestration got a major boost June 13 as House leaders vowed to take up the issue in future budget negotiations with the Senate.

In an effort to reduce the backlog of ANDA supplements, a review team within CDER’s Office of Generic Drugs (OGD) this month will start reviewing all backlogged supplements for drugs currently on the FDA’s shortages list.

Teva has reached a $2.15 billion settlement with Pfizer to resolve a long-running patent fight related to Pfizer’s acid reflux drug Protonix that had recently not been going in Teva’s favor.

Upcoming pharmacokinetic studies, evaluations of drug product characterizations, and postmarketing assessments of therapeutic equivalence are among a handful of new initiatives being launched this year by the FDA’s Office of Generic Drugs (OGD) to address regulatory science priorities for generic drugs identified for 2013 as part of GDUFA.

U.S. District Judge Edward Korman has agreed the government’s proposal to approve a new sNDA for Teva’s Plan B One-Step without age or point-of-sale restrictions satisfies his April 5 order.

State-level efforts to hinder substitution of biosimilar interchangeable products are premature and unfounded, a U.S. pharmacist group says, as Oregon and Delaware join a growing list of states moving to advance legislation that restricts the substitution of biosimilars for brand biologics.

Merck’s ‘353 patent for Nasonex in the U.S. is valid but won’t be infringed upon by Apotex’s 2009 ANDA for a generic version of the popular product, a federal appeals court ruled June 10.

Elite Pharmaceuticals filed a citizen petition with the FDA this month requesting permission to reference an approved ANDA product as the reference listed drug (RLD), in its latest effort to bring its discontinued extended release Lodrane products back to the market.

Sandoz subsidiary Ebewe Pharma has been warned for distributing parenteral drug products to the U.S. that were made using quality control methods not included in an approved application.

Seeking an avenue for a possible ANDA approval, CorePharma has petitioned the FDA to investigate whether Endo Pharmaceuticals discontinued its antipsychotic drug Moban in 2010 for reasons of safety and effectiveness, or as the generic drugmaker suspects, due to sourcing issues.

In response to a citizen petition from struggling startup IGI Labs, the FDA has determined that Aqua Pharmaceuticals’ discontinued topical corticosteroid ointment Cordran was not withdrawn from the market for safety and efficacy reasons, clearing the way for ANDA approval.

Drugmakers used comments to an FDA draft guidance on formal agency meetings for biosimilars to push for clarity on biosimilar user fees, with one company, Mylan, arguing the fees should be lower than those paid for drugs beholden to PDUFA requirements.