Pharmacies should be wary of potential drug name changes that could occur if FDA finalizes its new draft guidance on biosimilar naming, which proposes proper names for biosimilars.
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FDA has approved empagliflozin and metformin hydrochloride (Synjardy, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company) tablets for the treatment of adults with type 2 diabetes.
FDA has expanded approval of eltrombopag (Promacta, Novartis) to treat low blood platelet count in pediatric patients with chronic immune thrombocytopenic purpura.
Fortune describes the 5 fastest-growing US pharmaceutical manufacturers.
4 things formulary managers can do to save lives and resources.
FDA’s approval of the first 3D-printed pill – Spritam to control epileptic seizures – will have a major impact on the medical and pharmaceutical community as a whole.
FDA’s long-awaited approval of Addyi (flibanserin) to treat hypoactive sexual desire disorder in premenopausal women, is significant for the prescribing community.
Jardiance is the first diabetes drug that has also been shown to lower strokes, heart attacks and cardiovascular deaths, according to a new study.
FDA has approved sNDA for new formulation of fentanyl buccal soluble film (Onsolis, BioDelivery Sciences International) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant.
While FDA is proposing that bevacizumab (Avastin) for macular degeneration be used within 5 days of re-packaging to avoid development of endophthalmitis in patients, that precaution may not be necessary, according to a new study.
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FDA recently granted special approval of pediatric use of OxyContin in patients aged 11 to 16 years, under specific conditions.
A study of tocilizumab (Actemra) in the treatment of rheumatoid arthritis (RA) found that the number of serious adverse events (SAEs) found in postmarketing data were similar to other populations from clinical trials and epidemiology data.
Novo Nordisk is expected to find out in October whether FDA will approve its long-acting insulin Tresiba for sale in the US market. However, if approved, Tresiba faces growing competition from Sanofi, which markets the leading basal insulin Lantus along with Toujeo.
A Medicare reimbursement policy proposing that multiple biosimilars have the same pricing J-code for Medicare reimbursement purposes could ultimately result in fewer treatment options, according to a group representing the industry.
Surprisingly, giving prescriptions to the wrong patients is still common in community pharmacies across the U.S. According to the Institute for Safe Medication Practices (ISMP), this error occurs about once in every 1,000 prescriptions dispensed.
FDA has approved azelaic acid (Finacea, Bayer HealthCare) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.
Pharmaceutical firms “underinvest” in long-term research to develop new cancer-fighting drugs because of the time and expense, according to a new study.
FDA approved epilepsy drug levetiracetam (Spritam), the first FDA-approved drug that utilizes three-dimensional printing (3DP).
Unichem Pharmaceuticals issued a voluntary recall of Hydrochlorothiazide Tablets 25 mg, 1,000-count bottle. The precautionary measure is due to the identification of a Clopidogrel tablet found in a bottle at one pharmacy.
Global sales of pharmaceuticals will soar to $1.3 trillion in 2018, led by new cancer and specialty drug introductions, a new report found.
FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS).
After positive phase 3 trial data for its treatment for the bleeding disorder von Willebrand disease, Baxalta Inc. is awaiting FDA approval for the drug.
FDA has granted priority review to naloxone nasal spray (Indivior) for the treatment of opioid overdose. If approved, naloxone nasal spray is expected to be the first FDA-approved intranasal naloxone product indicated to treat opioid overdose in the United States.
There have been 8 high-profile FDA approvals in the last few weeks. Here is an overview.
On July 24, FDA approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections.
FDA has approved sonidegib (Odomzo, Novartis) for locally advanced basal cell carcinoma.
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