Category Archives: Generic Line

The FDA updated its guidance on communications with generics manufacturers to reflect the timelines agreed to in the second generation of the GDUFA program, which took effect Oct. 1.
Source: Generic Line

The number of “pay-for-delay” patent settlements agreed to by pharmaceutical companies in fiscal 2015 declined from the year before, according to a report from the Federal Trade Commission.
Source: Generic Line

The FDA is working to prevent manufacturers of branded high-risk drugs from stalling an application for approval of a generic competitor via manipulation of a requirement to share safety programs, Commissioner Scott Gottlieb said.
Source: Generic Line

A workers’ benefits fund filed a lawsuit claiming Johnson & Johnson maintained an illegal monopoly for its blockbuster drug Remicade, employing anticompetitive schemes involving insurer contracts, rebate protocols and bundling.
Source: Generic Line

The UK’s competition watchdog agency claimed the drugmaker Concordia overcharged the NHS by millions for its hypothyroid medication liothyronine, also known as Cytomel, following price increases of almost 6,000 percent over a decade.
Source: Generic Line

A health plan for a carpenters’ union filed a class action lawsuit against Celgene, claiming the drugmaker engaged in anti-competitive practices to maintain its monopoly on Thalomid (thalidomide) and Revlimid (lenalidomide).
Source: Generic Line

FDA Commissioner Scott Gottlieb told lawmakers the agency will work to break the stigma associated with medication-assisted treatments for opioid dependence and addiction.
Source: Generic Line

A federal judge declined to block Maryland’s new law on generic drug price-gouging that went into effect Oct. 1, but said a challenge based on the law’s vagueness can proceed.
Source: Generic Line

The FDA is streamlining its communications with generics manufacturers, and outlined its procedures for relaying the status of an ANDA review in a new manual for staff.
Source: Generic Line

In a new draft guidance, the FDA describes which abbreviated approval pathways are available for ANDAs and 505(b)(2) applications.
Source: Generic Line