FDAnews Drug Daily Bulletin

Generic-drug makers filing ANDAs and drug master files should provide six months of stability testing data, including accelerated and long-term conditions, and data from three pilot scale batches, or two pilot batches and one small scale batch, the FDA’s Office of Generic Drugs says in new draft guidance on stability testing.

Environmental monitoring programs, increasingly under scrutiny by FDA investigators, require continuous, top-level oversight and procedural accuracy to be effective, compliance experts say.

Janssen Biotech has submitted a BLA seeking approval of an IV formulation of Simponi to treat adults with moderate to severe rheumatoid arthritis (RA).

The health fund of an electrical workers’ union filed a class action against Warner Chilcott in Pennsylvania federal court over the pharmaceutical company’s alleged efforts to evade development of a generic Doryx by periodically tweaking the design and dosage of the anti-acne and bacterial infection drug.

Ranbaxy LaboratoriesBSE has missed out on the “first-day launch” of its generic version of Novartis’ blockbuster hypertension drug Diovan (valsartan) in the U.S., as it is yet to get the FDA’s approval for the generic version of the drug.

The FDA has tracked about 100 drug shortages this year, down almost half from this time last year, an agency official said.

Shares of Hemispherx Biopharma fell after the drugmaker said that the FDA has scheduled a meeting for December to review its experimental drug for chronic fatigue syndrome.

Mallinckrodt, the pharmaceuticals business of publicly held Covidien of Ireland, will pay $100 million in cash for St. Paul-based CNS Therapeutics, a five-year-old specialty pharmaceutical company.

Cedarburg Hauser Pharmaceuticals has expanded the capacity of its Grafton active pharmaceutical ingredient manufacturing plant to meet increased demand.