February 3, 2015

New York Attorney General Eric Schneiderman on Monday called on four major retailers to stop selling store-brand herbal supplement products in New York that could not be verified to contain the labeled substance by using what the industry describes as a questionable testing method — DNA barcoding.

February 2, 2015

The Food and Drug Administration announced that it has expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults, making it the first FDA-approved medicine to treat this condition.

 

January 30, 2015

Diplomat Pharmacy announced Thursday that the Food and Drug Administration has approved an expanded indication of Imbruvica (ibrutinib) for the treatment of Waldenström’s macroglobulinemia (WM).

January 30, 2015

Janssen Therapeutics on Thursday announced that the Food and Drug Administration has approved its Prezcobix (darunavir 800 mg/cobicistat 150 mg) tablets. The drug is used to treat human immunodeficiency virus in combination with other antiretovirals for treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions, according to the company.

 

January 27, 2015

Rep. Jason Chaffetz, R-Utah, last week introduced a bill that would extend to new combination drugs containing molecules already approved by the Food and Drug Administration the same five-year market exclusivity as a drug product containing an entirely new set of active ingredients.

January 27, 2015

The Food and Drug Administration on Monday announced approval for the first generic version of Nexium (esomeprazole magnesium delayed-release capsules), which are used to treat gastroesophageal reflux disease in adults and children ages 1 year and older.

January 26, 2015

The Food and Drug Administration last week approved Natpara (parathyroid horomone), which is indicated to control low blood calcium levels in patients who have hypoparathyroidism.

 

January 26, 2015

The Food and Drug Administration last week announced approval for Bexsero, a vaccine intended to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 years through 25 years of age.

 

January 21, 2015

Eisai on Tuesday announced the launch of a new savings card for Belviq (lorcaserin HCl) CIV, the most-prescribed branded FDA-approved prescription drug therapy for chronic weight management.

January 21, 2015

The Food and Drug Administration on Wednesday announced approval for Cosentyx (secukinumab), indicated for the treatment of adults with moderate to severe plaque psoriasis.

 

January 16, 2015

AbbVie announced that the Food and Drug Administration has approved its Duopa (carbidopa and levodopa) enteral suspension, which is used to treat motor fluctuations for people with advanced Parkinson's disease. 

 

January 16, 2015

Kathleen "Cook" Uhl on Thursday was named director of the Food and Drug Administration's Office of Generic Drugs.

 

January 14, 2015

The Food and Drug Administration established the Office of Pharmaceutical Quality, a new division tasked with improving quality control at pharmaceutical manufacturing facilities.

 

January 9, 2015

Daiichi Sankyo Co., Limited on Friday announced that the Food and Drug Administration has approved Savaysa (edoxaban) tablets, an oral, once-daily selective factor Xa-inhibitor that reduces the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. 

 

January 8, 2015

Sandoz may be on track to receive the first biosimilar drug approval from the Food and Drug Administration for its Zarxio.

January 7, 2015

With tens and possibly hundreds of billions of dollars in potential savings still snagged in a regulatory limbo, federal lawmakers and health industry stakeholders strongly urged the Food and Drug Administration last month to knock down the final barriers to review and approval of biosimilar drugs for marketing in the United States.

January 7, 2015

The pharmaceutical industry is back. Fueled by the launch of expensive, new biotech medicines, rising prices for both branded and generic drugs and a recent slowdown in branded-drug patent expirations and generic competition, the U.S. pharmaceutical market is staging a remarkable resurgence.

January 5, 2015

DSN examines chain pharmacy, including in-depth coverage of pharmacy technology, biosimilars and generics, as well as a Q&A with Owen Mumford's Travis Shaw, in this multi-page report.

December 30, 2014

Vertex Pharmaceuticals has announced that the Food and Drug Administration approved a supplemental new drug application for the use of Kalydeco (ivacaftor) in people with cystic fibrosis ages 6 years and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

December 29, 2014

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.

 

December 29, 2014

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.

December 29, 2014

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.

December 29, 2014

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.

December 23, 2014

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.