August 11, 2014

The recent release of Colgate Total’s application submitted to the Food and Drug Administration, which included 35 pages summarizing toxicology studies on triclosan, is raising some eyebrows as some are wondering if the FDA did its due diligence in approving Total 17 years ago, according to a report from Bloomberg Businessweek.

August 11, 2014

Janssen Pharmaceuticals received approval from the Food and Drug Administration for Invokamet, a fixed-dose therapy that combines canagliflozin and metformin hydrochloride in a single tablet.

August 11, 2014

The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.

August 8, 2014

The Food and Drug Administration earlier this week announced approval for Orbactiv (oritavancin), an antibacterial drug used to treat patients with acute bacterial skin and skin structure infections.

August 6, 2014

Michael Taylor, who currently serves as the Food and Drug Administration's deputy commissioner for foods and veterinary medicine, outlined the importance for companies to adhere to gluten-free guidelines in a post on FDA Voice.

August 4, 2014

The Council for Responsible Nutrition on Friday submitted comments to the Food and Drug Adminisration regarding the agency's proposed rule changes of nutrition and supplement facts labels. 

August 4, 2014

The Food and Drug Administration approved Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are younger than 8 years of age.

August 1, 2014

The Food and Drug Administration announced approval for Boehringer Ingelheim's Jardiance tablets.

August 1, 2014

The Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray for the treatment of chronic obstructive pulmonary disease, including chronic bronchitis and/or in patients with emphysema that are experiencing airflow obstruction, the agency announced.

July 31, 2014

The Food and Drug Administration on Friday will publish the fiscal year 2015 generic drug user fee rates as required under the Food Drug and Cosmetic Act as amended by the Generic Drug User Fee Amendments of 2012.

July 30, 2014

Perrigo on Wednesday announced that it has filed an abbreviated new drug application with the Food and Drug Administration for desoximetasone topical spray 0.25%. The company also has notified Taro Pharmaceuticals U.S.A., the owner of the reference listed drug, of the filing.

July 29, 2014

Legislation that would speed up and streamline the Food and Drug Administration’s approval process for new sunscreen ingredients passed the House on Monday, according to published reports.

July 29, 2014

The use of FDA drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending.

July 29, 2014

The Food and Drug Administration may have more generic drug applications than it does personnel to process them, according to a Wall Street Journal report published Tuesday.

July 28, 2014

The Food and Drug Administration on Monday expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia who carry a deletion in chromosome 17.

July 28, 2014

The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced Monday.

July 24, 2014

GlaxoSmithKline announced that the Food and Drug Administration has approved Flonase Allergy Relief as an over-the-counter treatment.

July 24, 2014

The Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), a long-acting opioid analgesic.

July 23, 2014

The Food and Drug Administration on Wednesday announced approval for Zydelig (idelalisib) to treat patients with chronic lymphocytic leukemia, relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma.

July 22, 2014

The Food and Drug Administration has granted tentative approval to Teva Pharmaceutical for abacavir sulfate and lamivudine tablets, according to agency records.

July 21, 2014

The Food and Drug Administration’s Center for Drug Evaluation and Research is providing an update to key leadership positions within the Office of Generic Drugs, the agency announced.

July 18, 2014

The Food and Drug Administration on Thursday announced the approval of Ruconest, a recombinant C1-Esterase inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema.

July 17, 2014

Purdue Pharma announced that the Food and Drug Administration approved a new 7.5-mcg/hour dosage strength of Butrans (buprenorphine) transdermal system CIII.

July 17, 2014

About 30% of top-performing OTC drugs today were once prescription-only medications noted Dave Wendland, VP Hamacher Resource Group, on Thursday during a videocast hosted by GMDC titled "Rx-to-OTC: Getting it Right at Retail."