April 2, 2013

DSN caught up with Greg Bradley — president and CEO of Advantage Consumer Healthcare, a full turnkey solution center for over-the-counter medicines reaching the market — for an overview of the new marketing and sales solution company as it has recently brought to market OraSure Technologies' OraQuick Advance, a take-home HIV test kit that the Food and Drug Administration recently approved for the self-care market, and Westport Pharmaceuticals' Zephrex-D, a pseudoephedrine product with a unique point of differentiation.

June 30, 2015

The GPhA's Biosimilars Council cautions FDA against adopting distinguishable names for biosimilars and biologics. 

June 30, 2015

The Food and Drug Administration on Tuesday issued guidance indicating that the agency would give pharmacies  an additional four months to comply with product tracing requirements scheduled to take effect July 1, 2015.

June 24, 2015

Pharmacy organizations have written a joint letter to the Food and Drug Administration asking officials to delay enforcement of a July 1 electronic product-tracing deadline for prescription drug dispensers.

June 23, 2015

Eisai announced Monday that the Food and Drug Administration had given Fycompa approval to be used as an adjunctive therapy in treating primary generalized tonic-clonic seizures.

June 23, 2015

The Food and Drug Administration is concerned that too great a deviance from a reference drug appearance could affect compliance. 

June 18, 2015

Aurobindo’s generic equivalent of anti-epileptic drug Dilantin has been approved by the Food and Drug Administration. 

June 17, 2015

The FDA has introduced a new website for Risk Evaluation and Mitigation Strategies, called REMS@FDA, to provide a standardized source of information about approved REMS.

June 16, 2015

The FDA announced on Tuesday that it determined that partially hydrogenated oils, the primary dietary source of artificial trans fat in processed foods, are not generally recognized as safe for use in human food.

June 15, 2015

DSN examines chain pharmacy, including in-depth coverage of technology, automation and generics, in this multi-page report.

June 15, 2015

Ralph Neas, president and CEO of the Generic Pharmaceutical Association, issued a statement Monday criticizing the FDA at the organization’s public meeting on the Generic Drug User Free Act.

June 15, 2015

Sens. Richard Blumenthal, D-Conn., and Sen. Dick Durbin, D-Ill., proposed three amendments to the National Defense Authorization Act that would impact how the military addresses supplementation. 

June 15, 2015

The credibility of the vitamins, minerals and supplements business has been attacked in recent months.

June 12, 2015

The drug is a daily oral treatment for children 6 and up with chronic immune thrombocytopenia (ITP).

June 8, 2015

The Food and Drug Administration hopes to boost the effectiveness of the influenza vaccine for this coming season, the Centers for Disease Control and Prevention reported. 

June 4, 2015

The Federal Trade Commission plans to examine the advertising practices of the homeopathy industry. 

June 4, 2015

Flublok uses an egg-free system, which means that manufacturing it doesn’t require influenza virus or antibiotics.

June 3, 2015

Mylan announced on Tuesday that it had launched its generic version of Teva’s  Seasonique birth control.

June 2, 2015
Aurobindo Pharma Limited has received approval from the Food and Drug Administration for its generic equivalent to Flagyl (metronidazole) tablets in 250- and 500-mg dosage strengths.  
 
May 29, 2015

The Food and Drug Administration Friday announced that it had approved Rapamune (sirolimus), distributed by Pfizer’s Wyeth Pharmaceuticals, as a treatment for the rare lung disease lymphangioleiomyomatosis (LAM). 

May 28, 2015

The U.S. Food and Drug Administration approved two treatments for irritable bowel syndrome with diarrhea (IBS-D) on Wednesday. 

May 26, 2015

The 21st Century Cures legislation would foster drug development. 

May 26, 2015

Aurobindo Pharma has submitted an abbreviated new drug application for dolutegravir 50 mg to the Food and Drug Administration for the treatment of HIV.

May 26, 2015

The Food and Drug Administration has approved Boehringer Ingelheim, Inc.'s Stiolto Respimat (tiotropium bromide and olodaterol), a once-daily inhaler meant to treat obstructed airflow in patients, the company announced Tuesday.