Drugs & Medical Devices Archives - Page 83 of 88

“Female Viagra” Drug, Flibanserin Approved by FDA on Third Attempt

Staff - August 19, 2015

Unlike its counterpart medications for male erectile dysfunction like Viagra or Cialis, Addyi will not be taken on an “as needed” basis. Citing differences in sexual function between men and women, clinical sex therapist Judy Kuriansky said, “Women’s sexuality is very complicated. It’s not a matter of just taking that pill, by the way, and then all of a sudden the lights go on.” Kuriansky added, “You have to feel good about your body. You have to feel good about yourself. You have to feel the guy really loves you. It’s complex.

Duodenoscope Sterilization a Focus as FDA Warns Three Device Makers

Staff - August 18, 2015

The regulator sent the letters to the Olympus, Fujifilm, and Pentax as part of an effort to fight against a wave of deadly bacterial infections attributed to the insufficient cleaning and sterilization of the devices. Duodenoscopes are reusable flexible tubes that go down the throat in order to treat gastrointestinal tract ailments.

Three More Birth-Defect Lawsuits add to GSK’s Zofran Tally as MDL Deadline Approaches

Staff - August 16, 2015

The lawsuits accuse GSK of “off-label” marketing, that is, it is prescribed for ailments (pregnancy) that is not mentioned in the drug’s official FDA labeling. Zofran’s 1991 FDA approval was for “treatment of nausea and vomiting related to chemotherapy and surgery.” According to San Francisco attorney Rachel Abrams, speaking at a bar conference in the city regarding the lawsuits, “If they’re marketing and pushing a drug for a certain indication, and don’t have FDA approval for that indication, that’s a problem for GSK in and of itself.”

FDA Warns Drugmaker Duchesnay over Kim Kardashian Instagram Post

Staff - August 14, 2015

Indeed the social media age has brought a new wrinkle in the FDA’s regulatory agenda. Social media marketing schemes are often designed to appear casual and conversational, as if friends are discussing an issue over coffee. While certainly not illegal and for the most part, and a useful form of advertisement, FDA risk statements rarely fit within 144 character-limit social-media parameters.

Medtronic Issues Recall for Newly-Approved Heart Device

Staff - August 8, 2015

Leading medical device manufacturer Medtronic has issued its second recall in as many weeks involving recently developed technology. Coming off of the European recall of its MiniMed 640 insulin pump last week, which is scheduled for a Pre-Market Approval (PMA) review in the U.S. later this year, the company has recalled nearly 7,000 EnVeo R

DOJ Subpoenas Allergan as Generics Antitrust Probe Widens

Staff - August 7, 2015

In the wake of a buying and selling frenzy, Irish drugmaker Allergan has been subpoenaed by the Department of Justice (DOJ) over antitrust concerns regarding the pricing of its generic drugs. Last week, the company announced a $40.5 billion selloff of its generics unit to the global generic market leader, Israeli-based Teva Pharmaceuticals. That deal

Will Medtronic’s MiniMed 640 Pump Glitch affect its PMA Status?

Staff - July 29, 2015

7/29/2015 Minnesota-based device giant Medtronic has issued letters to nearly 2,000 owners of the MiniMed 640 and 620 insulin pumps in Europe, warning them of a potential glitch in the reading mechanism. According to the letter, there is an error with the Bolus Wizard screen, causing it to not time-out and instead giving an outdated

Teva Inks $40.5 Billion Deal to Acquire Allergan’s Generics Unit

Staff - July 28, 2015

7/28/2015 The global pharmaceutical landscape was significantly altered on Monday as Israeli drugmaker Teva announced that it will purchase the generic drug business of Dublin-based Allergan. The move will put a stranglehold on Teva’s top sales position in the generic drug market, acquiring its third-largest competitor. Teva will purchase the generics unit for $40.5 billion,

FDA Sends C.R. Bard a Stern Warning for Unapproved Devices

Staff - July 23, 2015

7/23/2015 Los Angeles Food and Drug Administration (FDA) compliance officer Dr. Raymond W. Brullo issued a scathing warning letter to Thomas Ring, the CEO of New Jersey-based device manufacturer C.R. Bard. The letter contained a litany of violations regarding several single-use devices for IVC and foreign body retrieval. The letter follows a series of inspections

Medtronic’s Shiley Trach Tube Receives FDA’s Most Critical Recall

Staff - July 18, 2015

7/18/2015 The Food and Drug Administration (FDA) has given the recall of Medtronic’s Shiley neonatal and pediatric tracheostomy tubes a Class I label, its most serious designation. Under a Class I label, the FDA believes that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” Last

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