Generic Line

The FDA’s consent decree for Ranbaxy requires third-party audits of four facilities and it can be expanded to other plants if future inspections reveal compliance or data integrity issues, making it “unprecedented in scope,” the Department of Justice (DOJ) says.

While the global generics market is set to surge over the next five years as patents for blockbuster drugs expire, generic-drug makers would be wise to pad their portfolios with specialty products that are more difficult to produce, a new consultancy report states.

A federal appeals court has lifted an injunction that barred Watson Pharmaceuticals and Amphastar from selling a generic version of Sanofi’s blockbuster blood-thinner Lovenox — a decision that has yet to be finalized but that has emboldened the partners to launch the generic “immediately.”

The FDA is updating bioequivalence (BE) guidelines on more than five dozen drugs as it develops online product-specific BE recommendations for generic-drug sponsors.

Several Democratic lawmakers are requesting information from two brand drugmakers and the Drug Enforcement Administration (DEA) on production quotas that may limit generic attention deficit disorder (ADD) drugs.

Sandoz is looking to continue its global lead in biosimilars by launching two new Phase III trials on separate Amgen products.

Prosecutors are seeing a rise in lawsuits stemming from unsupported statements and superiority claims as competition between sponsors of brand and generic drugs heats up, Sara Bloom, assistant U.S. attorney for the District of Massachusetts, said. Bloom spoke at CBI’s 9th Annual Compliance Congress in Washington, D.C.

The FDA formally closed out a Jan. 14, 2010, warning letter citing Sunrise Pharmaceuticals for manufacturing some of its products with excess active pharmaceutical ingredient (API) without justification in the batch records.

Watson, a company that touts its ability to design and manufacture tough-to-make oral contraceptives, announced it has launched a generic version of Bayer HealthCare’s Yaz.

Drugmakers developing biosimilars of popular multiple sclerosis (MS) drugs containing interferon beta need only conduct in vivo studies in animals if in vitro bioassays raise concerns, updated European Medicines Agency (EMA) guidelines state.

A Hospira sales aid promoting Voluven for treating and preventing hypovolemia makes numerous unsubstantiated efficacy and comparative claims and downplays the drug’s risks, an FDA untitled letter states.

The European Medicines Agency (EMA) has updated its draft guidelines on drug master files with new language promoting sharing of drug data assessments among multiple EU authorities.