August 20, 2014

Despite creating a detailed plan to speed up the rate at which generic drug applications are reviewed, experts say a backlog has developed at the Food and Drug Administration’s Office of Generic Drugs.

August 19, 2014

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

August 19, 2014

Walgreens on Tuesday announced that flu shots are now available at all locations, including pharmacies and Healthcare Clinics.

 

August 18, 2014

The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities. 

August 18, 2014

Americans aspire to be healthier by making better food choices, but admit that the saying is a lot easier than the doing, according to a new white paper titled "Health and Wellness in America" released by Nielsen and the Natural Marketing Institute last week. 

August 14, 2014

Amneal Pharmaceuticals announced four new additions to its portfolio of generic drugs, which represent multiple therapeutic categories and account for $900 million annually in U.S. sales, the company said, citing data from IMS Health.

August 13, 2014

The European Union is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the decentralized procedure in real time with collaborating regulatory agencies outside the EU.

August 12, 2014

Rite Aid is getting a head start on the 2014-15 cold and flu season with the announcement Tuesday that seasonal flu shots are now available at Rite Aid pharmacies nationwide. 

 

August 12, 2014

Sanofi on Tuesday announced that it has launched an authorized generic version of Eloxatin (oxaliplatin injection) through Winthrop U.S., the company’s generics division. 

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The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved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 11, 2014

Fred's Super Dollar and Cardinal Health on Monday announced a multi-year agreement for Cardinal Health to be the new primary supplier of branded and generic pharmaceutical products.

August 11, 2014

Mylan announced the launch of capecitabine tablets USP in 150-mg and 500-mg dosage strengths, a generic version of Xeloda tablets from Genentech.

August 8, 2014

The BBC on Tuesday reported that a team has developed an app and small lens add-on that allows blood-cell analysis via a smartphone.

August 6, 2014

BD Medical, a segment of BD, on Wednesday announced the retail pharmacy launch of BD AutoShield Duo, the only pen needle with patented dual front- and back-end shields that provides greater convenience and safety before and after injecting. 

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.

August 5, 2014

One-in-four Americans admits that they have misused prescription drugs, according to a new national survey by FindLaw.com.

 

August 4, 2014

Cardinal Health on Monday reported fourth-quarter fiscal 2014 revenue of $23 billion, down 9.8%.

 

August 4, 2014

The Pennsylvania House of Representatives unanimously adopted House Resolution 938, which designates August as National Immunization Awareness Month, the legislature announced Monday.

July 31, 2014

Dr. Reddy's Labs announced financial results for the quarter ended June 30, which includes consolidated revenues of Rs.35.2 billion, representing year-on-year growth of 24%.

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 31, 2014

Teva Pharmaceuticals on Thursday announced results for second-quarter 2014, which included revenues of $5 billion, an increase of 2% compared with the same period last year.

July 31, 2014

McKesson on Thursday reported revenues of $44.1 billion for the first quarter ended June 30, up 37%. 

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

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.