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.

July 31, 2015

Bayer HealthCare Pharmaceuticals on Friday announced that the Food and Drug Administration approved the company’s Finacea (azelaic acid) Foam, 15% for the topical treatment rosacea.

July 28, 2015

The Council for Responsible Nutrition will host a conversation with key regulators of the dietary supplement industry at annual meeting. 

July 24, 2015

The Food and Drug Administration announced Friday that it approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and cirrhosis.

July 24, 2015

The Food and Drug Administration announced Friday that it had approved Novartis’ Odomzo (sonidegib). The drug is meant to treat basal cell carcinoma, the most common form of advanced skin cancer.

July 23, 2015

A new coalition has formed to ensure safe access to over-the-counter pain relief remedies. The Protecting Access to Pain Relief Coalition officially launched on June 22 to help ensure that American consumers continue to have access to, and choice of, safe and effective pain relief, including acetaminophen.

July 23, 2015

Lupin announced Thursday that it will acquire Gavis Pharmaceuticals and Novel Laboratories in a $880 million, cash- and debt-free transaction. 

July 21, 2015

Aurobindo Pharma announced Tuesday that the Food and Drug Administration had approved its generic version of Tambocor in 50-, 100- and 150-mg dosage strengths

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.