February 6, 2014

The Food and Drug Administration’s proposed rule on prescription drug labeling would add $4 billion annually to the nation’s healthcare costs, undercutting the cost savings that generic medicines have brought to America’s patients and healthcare system, according to an analysis released Wednesday by economic consulting firm Matrix Global Advisors.

February 4, 2014

The Food and Drug Administration on Tuesday unveiled its first youth tobacco prevention program, “The Real Cost,” which will target at-risk youth ages 12 to 17 who are open to smoking or already experimenting with cigarettes.

February 4, 2014

Salix Pharmaceuticals announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

February 3, 2014

The Food and Drug Administration is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products, the agency announced Friday.

February 3, 2014

The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization.

January 31, 2014

The Biotechnology Industry Organization and the Indiana Health Industry Forum commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

January 31, 2014

Valeant Pharmaceuticals International announced that it received approval from the Food and Drug Administration for Retin-A Micro (tretinoin) gel microsphere 0.08%.

January 30, 2014

Novartis Consumer Health will be relaunching Theraflu for the 2014-2015 cough-cold season, Brian McNamara, Novartis division head OTC, told analysts.

January 29, 2014

A pair of Food and Drug Administration advisory committees will be meeting Feb. 10 to talk about heart risks associated with use of NSAIDs and whether or not Bayer's Aleve (naproxen) carries a lower risk profile than other NSAIDs

January 29, 2014

Teva announced that the Food and Drug Administration approved its supplemental new drug application for three-times-a-week Copaxone in 40mg/mL form.

January 28, 2014

In 2012, compounding made headlines when 64 people died as a result of fungal meningitis caused by contaminated compounded products.

January 27, 2014

The Food and Drug Administration will hold a public meeting of the Allergenic Products Advisory Committee on Tuesday to determine the safety and efficacy of Ragwitek, a short ragweed pollen allergen extract tablet for sublingual use.

January 27, 2014

Walgreens Infusion Services on Monday announced that it has been selected as the preferred provider of home administration services for Makena (hydroxyprogesterone caproate injection), the only FDA-approved medication to help reduce the risk of preterm birth for clinically indicated patients.

January 24, 2014

Hi-Tech Pharmacal Co., a specialty pharmaceuticals company, announced that it was granted final approval from the Food and Drug Administration for bromfenac ophthalmic solution 0.09% (once-a-day).

January 24, 2014

Perrigo announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets.

January 22, 2014

The Food and Drug Administration launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees.

January 21, 2014

With the role of social media rapidly expanding, nearly half of pharmaceutical manufacturers are now actively using this channel to engage with patients on healthcare-related topics, according to a new report by the IMS Institute for Healthcare Informatics.

January 21, 2014

The Consumer Healthcare Products Association responded to Sen. Charles Schumer’s, D-N.Y., recent call for the Food and Drug Administration and the Consumer Product Safety Commission to require flow restrictors on all bottles of children's liquid medicines.

January 21, 2014

Teva Pharmaceutical announced that it has entered into a definitive agreement under which Teva will acquire NuPathe for $3.65 per share in cash.

January 21, 2014

Vivus and Auxilium Pharmaceuticals announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction."

January 20, 2014

Bayer's Advantage Multi for Dogs (imidacloprid + moxidectin) received Food and Drug Administration approval as the first-ever treatment for circulating microfilaria in heartworm-positive dogs.

January 20, 2014

The Food and Drug Administration recently approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (i.e., cannot be removed by surgery) or metastatic (i.e., late-stage), Onco360 announced last week.

January 17, 2014

The Consumer Healthcare Products Association responded to the Food and Drug Administration’s recommendation to discontinue prescribing and dispensing prescription combination medicines that contain more than 325 mg of acetaminophen per dosage unit, suggesting it would not impact use of over-the-counter formulations containing acetaminophen.

January 16, 2014

Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar.