Generic Line

Drugmakers may soon be able to get critical shortage drugs to market faster with a proposed shortcut for proving manufacturing compliance that’s included in draft legislation to reauthorize the FDA’s user fee programs.

The generic-drug industry’s freedom from liability for inadequate safety labeling could soon disappear if a key Democratic lawmaker has his way.

Rep. Elijah Cummings (D-Md.) and Sens. John D. Rockefeller (D-W.Va.) and Tom Harkin (D-Iowa) sent letters March 21 to three licensed pharmacies accused of transferring drugs to wholesale companies owned by the same individuals instead of dispensing drugs to patients per their licenses.

ATHENS, Ga. — Generic-drug makers need to pay closer attention to the quality and source of their excipients as regulators are likely to enforce new quality standards that trade groups are drafting, a former chair of the International Pharmaceutical Excipients Council (IPEC) says.

A federal appeals court has agreed with a lower court that ViroPharma lacks standing to sue the FDA for changing bioequivalence testing standards for generic drugs referencing its gastrointestinal antibiotic Vancocin.

Canadian generic giant Apotex is suing the U.S. government, saying the FDA’s 2009 import ban on two of its Ontario plants “decimated” its U.S. business and violated the North American Free Trade Agreement (NAFTA).

BALTIMORE — Drugmakers are expected to push for details on how the FDA will review biosimilars applications that reference biologics approved outside the U.S.

Abbott is challenging Watson Laboratories’ ANDA for its billion-dollar cholesterol drug Niaspan, claiming the company is infringing on two patents.

The FDA has given Teva and a subsidiary the green light to market the generic versions of Forest Laboratories’ blockbuster antidepressant Lexapro, granting the generic giant 180-day exclusivity as first filer.

On the eve of possible approval for generic competition to one of AstraZeneca’s blockbuster franchises, a judge has denied the company’s request for an injunction barring final FDA approval for follow-ons of its antipsychotic Seroquel.

Generic-drug makers are seeing product liability cases thrown out left and right, with judges ruling they’re not required to change labels to reflect new safety concerns until after the brand drugmaker changes its labeling.