Generic Line

The FDA has appointed a former brand-drug industry executive for the long-vacant top spot at Office of Generic Drugs (OGD).

The FTC’s fight against what it calls “pay-for-delay” settlements received a boost Monday when the Third Circuit Court of Appeals reversed a lower court ruling that had upheld a reverse patent settlement.

An Ohio District Court ruling that the FDA can approve generics on a withdrawn brand product could spell bad news for brand drugmakers trying to ward off generic competition.

President Barack Obama signed a bill that creates new user fee programs for generic drugs and biosimilars into law now giving the FDA almost three months to before fully launching the programs.

In reconciling the FDA Safety and Innovation Act, S. 3187, lawmakers made one technical tweak to the bill.

A provision in the 2007 FDA Amendments Act (FDAAA) intended to limit citizen petitions that block generic drug approvals has failed to change the behavior of brand companies, whose use of the petitions continues to rise, according to a new study.

The FDA has warned Spanish industrial giant and active pharmaceutical ingredient (API) maker Ercros S.A. for good manufacturing practice (cGMP) nonconformities, including various validation lapses and building disrepair that invites pests.

Like its FDA counterparts, Indian regulators promise fewer clinical trials for biosimilars makers who can prove their product closely matches its reference product, according to new guidelines.

Bedford Laboratories is voluntarily recalling three lots of its chemotherapy drug leucovorin calcium after receiving complaints of crystalline particulates in a small number of vials.

Teva Pharmaceuticals won two major patent cases on its best-selling product in multiple sclerosis treatment Copaxone, warding off generic competition for a few more years.

Developers of biosimilar monoclonal antibodies (mAb) must conduct nonclinical and clinical studies that compare the biosimilars with the original mAb to detect any relevant differences between the two products, according to a final European Medicines Agency (EMA) guideline.

Hospira is looking into a supplier glass defect following consumer complaints and a Health Canada warning to physicians not to use three lots of its cancer treatment paclitaxel injection, 300 mg/50 mL.

Five retailers have sued Pfizer and Ranbaxy, alleging the drugmakers conspired to delay market entry of generic Lipitor in the U.S.

BOSTON — Language in the finalized FDA user fee bill requiring early notification on manufacturing changes that could create drug shortages is so vague that drugmakers will flood the agency with reports, causing more harm than good, a former FDA associate commissioner says.