A survey co-released by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that 8-in-10 healthcare providers have serious concerns about a proposed Food and Drug Administration rule on generic drug labeling.
According to a report from the American Academy of Family Physicians, the Advisory Committee on Immunization Practices for the Centers for Disease Control and Prevention voted unanimously to recommend that healthy children between the ages of 2 years and 8 years be inoculated with a live attenuated influenza vaccine like FluMist, as opposed to the traditional flu shot.
A study published Tuesday online by the journal Pediatrics found that the protective benefits provided by vaccines for children significantly outweighed the extremely rare possiblity of an adverse event.
Health care providers wrote 259 million prescriptions for opioid painkillers in 2012 — many more in some states than in others — according to a Vital Signs report released Tuesday by the Centers for Disease Control and Prevention that highlights the danger of overdose.
The Food and Drug Administration on Tuesday issued several policy documents regarding compounding as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act enacted in November 2013.
Actavis on Wednesday announced that its subsidiary Forest Labs has successfully completed its acquisition of Furiex Pharmaceuticals in an all-cash transaction valued at approximately $1.1 billion, and up to approximately $360 million in a Contingent Value Right that may be payable based on the status of eluxadoline, Furiex's lead product, as a controlled drug, following approval.
As many as 32 organizations on Tuesday signed a letter calling on the Food and Drug Administration to require biologics and biosimilars to have the same International Nonproprietary Name, a practice currently in use in Europe and other markets.
Upsher-Smith Laboratories on Wednesday announced the launch of testosterone gel (1%), the generic of Vogelxo (testosterone) gel 1%, for topical use. Newly approved by the Food and Drug Administration, it is the first and only available generic testosterone replacement therapy available in three configurations, the company stated.
Actavis on Monday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration to market buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets.
The Food and Drug Administration on Thursday notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain.
Ohm Labs, a wholly owned subsidiary of Ranbaxy Labs, on Friday announced that it received approval from the Food and Drug Administration to manufacture and market valsartan tablets in 40 mg, 80 mg, 160 mg and 320 mg dosage strengths.