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.
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.
Capitol Hill staffers this week learned useful tips from a medical expert on reading and understanding dietary supplement labels, and received a primer on the depth of regulation behind dietary supplement labeling during an educational briefing held by the Congressional Dietary Supplement Caucus in cooperation with the leading trade associations representing the dietary supplement industry, the group announced Friday.
The Advisory Committee on Immunization Practices on Wednesday voted to recommend a preference for using the nasal spray flu vaccine instead of the flu shot in healthy children ages 2 years to 8 years of age when it is immediately available.
Massachusetts Governor Deval Patrick on Tuesday enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed "interchangeable" by the Food and Drug Administration.
Pharmacists in Pennsylvania may soon be required to notify physicians prior to substituing a biologic medicine with a biosimilar medication following the passing of a bill by the Pennsylvania Senate, the Associated Press reported Tuesday.
Nikki Haskell, the owner and CEO of Balanced Health Products, has been sentenced by a U.S. magistrate judge in a Manhattan federal court to a $60,000 fine for distributing dietary supplements that contained a prescription drug, the Food and Drug Administration reported Monday.
The National Advertising Division last week determined that Westport Pharmaceuticals, maker of Zephrex-D nasal decongestant tablets, can support the claims challenged before NAD by Acura Pharmaceuticals, the maker of Nexafed, a competing product.
The Food and Drug Administration has published a draft guidance document for prescription drug supply chain stakeholders as part of the agency’s implementation of the Drug Supply Chain Security Act, the National Association of Boards of Pharmacy has reported.
Actavis confirmed that the U.S. District Court for the District of Delaware found certain claims of U.S. Patent Nos. 6,335,031 and 6,316,023 valid and infringed by the company's rivastigmine transdermal system, a generic version of Exelon Patch from Novartis.
Canada’s Federal Court ruled recently that the country’s Patented Medicine Prices Review Board — a federal tribunal that regulates pricing on branded medicines — could not extend price-control measures to cover generic drug companies, according to published reports.
As patients across North America continue to turn to their neighborhood pharmacy for vaccinations, state and provincial governments in the United States and Canada are widening the range of immunizations that can be administered by a pharmacist.
A survey co-released Wednesday 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.