March 23, 2015

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

March 5, 2015

Nutramax Labs announced Thursday the results of a National Institutes of Health-funded clinical study carried out at the Fred Hutchinson Cancer Research Center in Seattle.

 

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.”

 

February 26, 2015

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

February 24, 2015

Shire on Tuesday acquired Meritage, which includes the phase 3-ready compound Oral Budesonide Suspension for the treatment of adolescents and adults with eosinophilic esophagitis.

February 18, 2015

Acura Pharmaceuticals on Monday announced the initiation of treatment in a pilot clinical study of two experimental formulations of Nexafed (pseudoephedrine HCl) extended-release tablets.

February 17, 2015

CVS Health weighs in on the next chapter in the debate about the impact of expensive drugs on the healthcare system in a commentary that appears today on the Health Affairs blog.

February 9, 2015

Daiichi Sankyo on Monday announced that its Savaysa (edoxaban) tablets are now available in pharmacies across the United States. The drug was granted approval from the Food and Drug Administration on Jan. 8 and is used to reduce the risk of stroke and systemic embolism in patients who have a non-valvular atrial fibrillation, as well as for the treatment of deep vein thrombosis and pulmonary embolism, the company said.

February 3, 2015

Zogenix last week announced that the Food and Drug Administration approved a new formulation of the company's Zohydro ER (hydrocodone bitartrate) extended-release capsules, CII.

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

Teva Pharmaceutical Industries announced that the Food and Drug Administration approved the company’s first generic Nexium delayed-release tablets in the United States.

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 7, 2015

Lupin Pharmaceuticals on Tuesday launched its valsartan tablets USP in 40-, 80-, 160- and 320-mg dosage strengths. The drug is the generic version Novartis's Diovan tablets.

January 7, 2015

Teva Pharmaceutical on Tuesday announced the Food and Drug Administration approved the launch of the company's valsartan tablets, the generic version of Diovan tablets from Novartis. 

 

January 6, 2015

Aurobindo Pharma on Tuesday announced that the company has received final approval from the U.S. Food & Drug Administration to manufacture and market Valsartan Tablets.

January 5, 2015

Keryx Biopharmaceuticals last month announced it has begun shipping Auryxia (ferric citrate) tablets to wholesalers in the United States. 

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

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 23, 2014

Teva Pharmaceutical today announced that the Food and Drug Administration has approved Granix (tbo-filgrastim) Injection for self-administration by patients and caregivers. With the approval of this additional administration option, physicians will soon have the flexibility to prescribe Granix for either in-office or at home use.

December 12, 2014

Sanofi Pasteur announced that the FDA approved the supplemental biologics license application for Fluzone Intradermal Quadrivalent vaccine.

November 17, 2014

Genzyme, a Sanofi company, on Friday announced that the Food and Drug Administration approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis. 

November 17, 2014

Drug Store News caught up with Upsher-Smith chief commercial officer Rusty Field to discuss topiramate extended-release capsules, its new authorized generic to Qudexy XR.

November 7, 2014

Teva Pharmaceutical on Friday announced positive findings from a Phase III clinical study that examined the safety and efficacy of Qnasl.

October 30, 2014

AstraZeneca on Thursday announced that the Food and Drug Administration approved Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily drug for the treatment of adults with Type 2 diabetes.