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. 

October 29, 2014

Consumers want to know: do disinfectant products like Reckitt Benckiser's Lysol or Clorox protect against the Ebola virus?

October 21, 2014

Boehringer Ingelheim Pharmaceuticals on Monday announced that Ofev (nintedanib) capsules are now available in the United States. Ofev was approved by the Food and Drug Administration on Oct. 15 to treat idiopathic pulmonary fibrosis.

October 10, 2014

The Food and Drug Administration on Friday approved Gilead's Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus genotype 1 infection.

October 8, 2014

Teva Pharmaceutical Industries on Wednesday announced the initiation of a rolling new drug application submission for hydrocodone bitartrate extended-release tablets.

September 11, 2014

Medivation and Astellas Pharma on Wednesday announced that the Food and Drug Administration approved a new use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer.

September 9, 2014

Sanofi Pasteur announced that the Food and Drug Administration approved the use of Menactra [meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine] as a booster vaccination against meningococcal disease in people ages 15 years through 55 years. 

September 5, 2014

Merck on Thursday announced that the Food and Drug Administration granted accelerated approval to Keytruda (pembrolizumab) for the treatment of patients with advanced melanoma.

August 26, 2014

Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Co. announced that Jardiance (empagliflozin) tablets are now available by prescription in pharmacies across the United States.

August 19, 2014

The Food and Drug Administration has approved Mylan Institutional’s application for its dexmedetomidine hydrochloride injection, the company announced Tuesday. 

August 5, 2014

Lannett Co. on Monday announced that its abbreviated new drug application for oxycodone hydrochloride capsules, 5 mg, has been approved by the Food and Drug Administration.