Mylan on Thursday announced that the U.S. District Court for the district of New Jersey granted its motion for a permanent injunction against GlaxoSmithKline in relation to paroxetine CR, the generic version of GSK's Paxil CR.
RetireSafe, a grassroots organization advocating on behalf of America’s seniors on Tuesday released a survey finding that seniors overwhelmingly support strong patient safeguards for biosimilar medications.
Teva Pharmaceuticals on Monday announced that the Food and Drug Administration has accepted the company's new drug application for albuterol multi-dose dry-powder inhaler, a breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease.
Anacor Pharmaceuticals announced that the Food and Drug Administration has approved the company's new drug application for Kerydin (tavaborole) topical solution, 5% — an antifungal approved for the topical treatment of onychomycosis of the toenails.
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.
As the healthcare landscape continues to change at a rapid pace, the National Association of Chain Drug Stores is supporting a bipartisan initiative aimed at accelerating the pace of cures and medical breakthroughs in the United States.
On June 25, the U.S. Department of Justice, at the request of the Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede of Rancho Dominguez, Calif., and its president, Michael Pellico.
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.
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.
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.
The Acetaminophen Awareness Coalition on Thursday released “Acetaminophen: How It’s Used, Preventing Overdose and What We Can Do to Promote Safe Use,” a report and educational resource to drive safe and appropriate use of one of the United States’ most common drug ingredients.
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.