March 23, 2015

Acura Pharmaceutical's Nexafed extended release demonstrated bioequivalence to Sudafed 12-hour tablets. 

March 19, 2015

In a letter to the Senate, the Food and Drug Administration acknowledged that DNA barcoding is not routinely used to identify botanical ingredients. 

March 13, 2015

Actavis on Friday announced that the Food and Drug Administration approved Saphris for the treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients.

March 11, 2015

A coalition of state attorneys general is organized by New York Attorney General Eric Schneiderman to investigate herbal supplements. 

 

March 10, 2015

The Food and Drug Administration recently published bio-equivalence guidance documents. 

March 9, 2015

DSN examines chain pharmacy, including in-depth coverage of provider status, kiosks, Medicare and the GPhA elections, in this multi-page report.

March 6, 2015

The Food and Drug Administration approved Zarxio, making it the first approved biosimilar product in the United States.

March 4, 2015

DexCom received Food and Drug Administration approval for its Dexcom G4 Platinum Continuous Glucose Monitor System with Share. The Share receiver uses a wireless connection via Bluetooth Low Energy between the patient’s receiver and an app on the patient’s smartphone to relay glucose information to apps on the mobile devices of up to five designated recipients, or “followers.”

 

March 2, 2015

The FDA is expected to issue new guidance on biosimilars labeling and generic opioids before the end of year, according to a report by the Regulatory Affairs Professional Society.

February 26, 2015

Congress introdues legislation to protect FDA user fees from sequestration. 

February 26, 2015

The fixed-combination drug Avycaz was granted priority review by the Food and Drug Administration. 

February 26, 2015

Sanofi expands its portfolio of insulin therapy products with the introduction of the once-daily, long-acting Toujeo. 

February 24, 2015

The Food and Drug Administration is looking into enabling holders of abbreviated new drug applications to unilaterally update their generic drug product labels prior to any branded drug change. 

February 24, 2015

NPA  renewed its call to the New York Attorney General to produce the scientific evidence behind that office's recall request of herbal supplements.

February 23, 2015

Combined Distributors reported that its medicine disposal product was found to exceed U.S. FDA and EPA guidelines. 

February 20, 2015

FDA makes direct-to-consumer genetic testing easier to bring to market. 

February 17, 2015

The Food and Drug Administration has approved Lenvima (lenvatinib) for the treatment of differentiated thyroid cancer. 

February 17, 2015

The Food and Drug Administration last week issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions.

February 13, 2015

In response to the New York Attorney General’s recent recall of herbal supplements from four major retailers, the Council for Responsible Nutrition has assembled a microsite for consumers.

February 10, 2015

GNC on Monday announced that it refuted the claims made by the New York State Attorney General in his Feb. 2 letter.

February 6, 2015

The pharma industry praised outgoing Food and Drug Administration commissioner Margaret Hamburg and welcomed Stephen Ostroff, who will assume the role of acting commissioner.

February 5, 2015

In this issue, DSN looks at another three hot spot issues identified by PwC’s HRI that will help define how health care is provided in 2015.

February 5, 2015

Food and Drug Commissioner Margaret Hamburg will resign from her post in March.

 

February 5, 2015

Generic drug prices are going up. Spurred by market opportunities, short-term market exclusivity for some newly launched single-source generics and rising costs for manufacturing, quality control and raw materials, me-too drug manufacturers have escalated a series of price hikes, some of them significant.