01/05/2015 - 3:15pm

About half the country is experiencing high levels of flu activity.

 

01/05/2015 - 2:20pm

Mylan announced the introduction of valsartan tablets USP in 40-, 80-, 160- and 320-mg dosage strengths. 

01/05/2015 - 1:58pm

Keryx Biopharmaceuticals last month announced it has begun shipping Auryxia (ferric citrate) tablets to wholesalers in the United States. 

12/29/2014 - 11:26am

Genentech last week announced that the Food and Drug Administration approved a supplemental biologics license application for Gazyva to be used in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia.

12/29/2014 - 10:46am

In a staff memo, the Office of Generics Drug’s acting director, Kathleen Uhl, vowed to take action on 90% of the abbreviated new drug application backlog before October 2017, and has appointed Ted Sherwood as acting director of OGD’s Office of Regulatory Operations to help with the improvements, FDANews.com has reported.

12/29/2014 - 10:29am

Novo Nordisk last week announced that the Food and Drug Administration approved the company's new drug application for Saxenda, a once-daily glucagon-like peptide-1 receptor agonist used as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults.

12/29/2014 - 10:07am

Actavis and Adamas Pharmaceuticals last week announced that the Food and Drug Administration approved Namzaric. According to the companies, the drug is used to treat moderate to severe dementia of the Alzheimer's type in patients stablized on memantine hydrochloride and donepezil hydrochloride.

 

12/23/2014 - 11:34am

Specialty pharmacy Diplomat Pharmacy has announced that it will stock Viekira Pak (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets), which was approved Dec. 19 by the Food and Drug Administration.

12/22/2014 - 10:59am

The Food and Drug Administration has approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections and complicated urinary tract infections.