GlaxoSmithKline Plc’s much-maligned diabetes drug Avandia will be released from restrictions preventing sales to certain patients after U.S. regulators determined new data show the medicine doesn’t raise heart risks.
Generic drug companies will be able to publicize new safety information on a product on their own instead of waiting for their brand-name counterparts to release the information under a plan from U.S. regulators.
Vicodin and other hydrocodone-based painkillers, the most popular pharmacy drugs in the U.S., would be placed under stricter prescribing limits to curb abuse, in a policy reversal by the Food and Drug Administration.
Zogenix Inc. won approval to sell the first painkiller made of pure hydrocodone as U.S. regulators recommended restrictions on popular combination treatments with the drug. The decision helped Zogenix shares climb the most in eight months.
Drugmakers may win approval from U.S. regulators for “breakthrough” therapies after a single round of studies, rather than three, in an effort to speed them to patients, a Food and Drug Administration official said.
Half of the 21 drugs pulled from the market in the U.S. for safety reasons since 1995 involved heart complications, a finding that is spurring Congress and doctors to call for closer government review of side effects.
April Hauge, a nurse practitioner in Weimar, California, spent $500 on a genetic test for her autistic son in 2009 that led to purchasing thousands of dollars in vitamins and supplements. Impressed with the results, she’s now selling advice on the approach to others.
The Food and Drug Administration is weighing whether to let consumers buy medicines for some chronic conditions without a prescription while speeding approvals of drugs for infection, Alzheimer’s disease and rare conditions.
Drug cocktails for cancer, heart disease and other conditions may reach the U.S. market sooner under new guidelines that let companies seek approval for a combination of two or more medicines at the same time.