July 17, 2015

Injectable and infusion drug company Hospira announced Thursday that the Food and Drug Administration had approved its bivalirudin injection, a generic of the Medicine Company’s Angiomax.

July 16, 2015

Galderma Laboratories announced Thursday that the Food and Drug Administration had approved it Epiduo Forte Gel, an antibiotic-free daily treatment for acne vulgaris.

July 16, 2015

The Food and Drug Administration recently issued its final guidance on the appearance of generic pharmaceuticals, recommending that drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs that they reference.

July 16, 2015

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

July 15, 2015

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

July 15, 2015

A collection of eight consumer groups have written to Federal Trade Commission chair Edith Ramirez in opposition of the ongoing potential merger between pharmaceutical companies Teva and Mylan. 

July 15, 2015

The Food and Drug Administration is exploring extending PDUFA through 2022. 

July 13, 2015

Otsuka Pharmaceutical and H. Lundbeck A/S announced Friday that their new medication Rexulti (brexpiprazole) had been approved by the Food and Drug Administration as an adjunctive treatment for major depressive disorder (MDD) and a treament for schizophrenia. 

July 13, 2015

Theranos is expanding what it started two years ago in the Phoenix market with a new Pennsylvania partnership and a recent FDA approval. 

July 9, 2015

 Mylan announced Thursday that it had launched its generic version of Valeant’s Targretin (bexarotene) 75-mg capsules.

July 6, 2015

The Food and Drug Administration recently approved Orkambi a new cystic fibrosis treatment that received designation from the FDA as a breakthrough therapy and as an orphan drug. 

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).