March 25, 2014

Mylan on Monday announced the U.S. District Court for the Northern District of West Virginia ruled in favor of upholding the validity of patents protecting Perforomist (formoterol fumarate) Inhalation Solution.

March 24, 2014

Genentech announced that the Food and Drug Administration approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, or CIU, which is a form of chronic hives.

March 24, 2014

Celgene on Friday announced that the Food and Drug Administration has approved Otezla (apremilast), the company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis.

March 21, 2014

Actavis earlier this week announced that it has entered into an agreement with Noven Pharmaceuticals to settle all outstanding patent litigation related to Actavis' generic version of Daytrana (methylphenidate transdermal system).

March 20, 2014

The Food and Drug Administration announced the approval of Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Leishmaniasis is caused by Leishmania, a parasite transmitted to humans through sand fly bites.

March 19, 2014

The Electronic Retailing Self-Regulation Program on Tuesday announced it will refer direct response advertising for Dinamo to the Federal Trade Commission and the Food and Drug Administration after the marketer, Natures Flava, failed to respond to an ERSP inquiry.

March 19, 2014

Ferring Pharmaceuticals announced that it received approval from the Food and Drug Administration for new labeling of its fertility products Menopur and Bravelle.

March 18, 2014

Avella Specialty Pharmacy announced that it has registered with the Food and Drug Administration as an outsourcing facility for sterile compounding as outlined in the recently enacted Drug Quality and Security Act.

March 18, 2014

The Consumer Healthcare Products Association this year will be focusing on restoring OTC eligibility under flexible spending accounts and helping to finalize OTC monographs, Scott Melville, CHPA president and CEO, told attendees of the 2014 CHPA Annual Executive Conference Tuesday morning.

March 18, 2014

Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.

March 18, 2014

Natco Pharma received tentative approval from the Food and Drug Administration to launch a generic version of Roche Holding AG's Tamiflu, according to a recent report. The drug is used to treat bird and swine flu.

March 18, 2014

Pfizer has sued Torrent Pharmaceuticals in an effort to protect its erectile-dysfunction drug Viagra (sildenafil citrate) from generic competition, according to a Bloomberg News report published Tuesday.

March 17, 2014

Bristol-Myers Squibb Co. and Pfizer announced that the Food and Drug Administration approved a supplemental new drug application for Eliquis (apixaban). The drug is a preventive treatment for deep vein thrombosis, which can lead to pulmonary embolism for patients who have had hip or knee replacement surgery.

March 17, 2014

Pierre Fabre Dermatologies announced that it received authorization from the Food and Drug Administration to market the pediatric drug Hemangeol (propranolol hydrochloride).

March 14, 2014

Legislation introduced to unclog the backlog of sunscreen ingredients and streamline the review process for faster public access has garnered the accolades of the Public Access to SunScreen Coalition.

March 13, 2014

Using azithromycin and levofloxacin increases the risk of cardiac arrhythmia and death, according to a study of U.S. veterans.

March 12, 2014

Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

March 12, 2014

Walmart has joined almost two-dozen organizations from across the healthcare supply chain in a letter calling on the Food and Drug Administration to consider the public health impact of its Proposed Rule on pharmaceutical labeling.

March 10, 2014

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines.

March 10, 2014

Two Rx-to-OTC switches in the past year may serve as a harbinger of what the Food and Drug Administration will consider “switch” worthy.

March 10, 2014

A Maryland bill that is intended to help pharmacies in managing inventories and avoid potential drug shortages could create hardships for distributors, according to an FDA law blog.

March 7, 2014

It's finally happening. Pfizer has placed the ball at the line of scrimmage. And based on the X's and O's to come out of its Lipitor OTC actual-use study, Pfizer will be making its run with its eye on the ultimate prize — a successful Rx-to-OTC switch of a statin.

Only this time, the Food and Drug Administration may not be as quick to sack Pfizer's switch attempt. With the advances and pervasion of health technology in the self-care space by way of smartphones and tablets; with the evolution of the pharmacist as a healthcare professional able to practice at the top of their license; and with the adoption of diagnostic tests like a cholesterol panel that can be physically administered in the pharmacy, consumers may finally get it right when self-selecting a statin.

Because it's the consumer actual-use studies that have scuttled just about every statin switch attempt in the past. In the last switch of Mevacor, FDA advisory panelists determined the statin was safe enough for the self-care space. And it was effective. It's just that the consumers who would be right for an OTC statin didn't appropriately self-select. And if they can't appropriately self-select, what's the point, really?

March 7, 2014

A study published online Friday shows that the omega-3 fatty acids EPA and DHA — commonly found in fatty fish and fish oil supplements — are as effective, if not more effective, in lowering blood pressure as some of the commonly recommended lifestyle changes like increasing physical activity and restricting alcohol and sodium intake.

March 6, 2014

In anticipation of the March 13 deadline for comments on the FDA's proposed rule on prescription generic drug labeling, 21 health industry groups submitted a new letter to the agency on Thursday, raising concerns about the proposed regulation.