FDAnews Drug Daily Bulletin

The FDA has approved an expanded indication for Pfizer’s Lyrica CV to treat neuropathic pain due to spinal cord injury, boosting the pharma giant’s fast-growing pain management portfolio.

To smoothly transition clinical investigation oversight from one IRB to another, new and old IRBs, clinical investigators, sponsors and CROs should work closely to minimize disruptions to the ongoing trial and ensure subjects are constantly protected, according to a new draft guidance.

Novo Nordisk will have to wait until late October to get word on the fate of two ultra-long-acting insulin treatments because the FDA needs additional time to review data clarifications and analyses it requested after the initial NDA submissions.

With China amending its patent law on compulsory licensing soon after India granted the first such permit in the country, innovator pharmaceutical firms that bank on patent protection for growth are under pressure to revamp sourcing, distribution and pricing strategies, industry experts said.

A drug used for treating high blood pressure has been linked with a number of severe gastrointestinal side effects.

European drug regulators recommended restricting the use of tolperisone and trimetazidine-containing medicines due to worries about the risk-benefit balance.

Novartis AG’s new $150 million manufacturing plant outside St. Petersburg will be built in two years, Joseph Jimenez, chief executive officer of the Swiss pharmaceuticals company said.

Teva Pharmaceutical has launched Olanzapine and Fluoxetine Capsules USP 6mg/25mg, 12mg/25mg, 6mg/50mg and 12mg/50mg.

A worker at a Hauppauge pharmaceutical company has been convicted of illegal distribution of hydrocodone after federal prosecutors said he stole four pounds of the painkiller from the business — enough to make hundreds of thousands of tablets of the narcotic, federal officials said.