FDA approval 111 articles

On March 9, 2016, the U.S. Food and Drug Administration (FDA) approved the first generic version of Pfizer Inc.’s Viagra. Law360 reports that Teva Pharmaceutical Industries Ltd.’s abbreviated 25-, 50- and 100-milligram sildenafil citrate tablets were all approved and the company will have market exclusivity for the next 180 days. However, due to a 12-day bench trial in 2011 where Pfizer sued Teva to enforce its patent, the generic could not be sold until the patent expired in 2019 or until permitted by the licensing agreement. According to CBS News and RAPS.org Teva will begin selling the drug Dec. 11, 2017. RAPS.org ... Read More

Plaintiffs suing Johnson & Johnson’s unit Janssen Pharmaceuticals for injuries caused by off-label use of the companies’ antipsychotic drug Risperdal are asking a Pennsylvania judge to reconsider an order that shields the companies from punitive damages. Plaintiffs instead are asking Judge Arnold New with the Philadelphia County Court of Common Pleas to order that punitive damages in the Risperdal mass tort program be made on a case-by-case basis. Judge New ruled in May that the Risperdal mass tort be administered by New Jersey law, which includes a Products Liability Act that bars punitive damages in lawsuits on drugs that are approved ... Read More

In the latest battle against prescription drug abuse, the City of Chicago has filed a lawsuit against five drug companies alleging they engaged in deceptive marketing practices for their highly addictive painkillers to reel in extra profit. The lawsuit, filed this week in Cook County Circuit Court, claims the pharmaceutical companies pushed long-term use of their powerful opioids to treat non-cancer pain, which was false, misleading and “unsupported by science.” The lawsuit comes just one month after two California counties filed a similar lawsuit against the same five drug companies – Johnson & Johnson’s Janssen Pharmaceuticals, Purdue Pharma, Actavis, Endo ... Read More

Just weeks after the Food and Drug Administration (FDA) refused to take the advice of medical doctors, anti-drug abuse groups, and several attorneys general to reconsider its approval of the powerful new opioid Zohydro, another drug company announced that the agency has agreed to review its investigational extended-release oral formulation of the same narcotic plus acetaminophen. Critics warned the FDA that approving another powerful opioid would only fuel an already growing epidemic of prescription drug abuse. Opioids, which include the medications morphine and oxycodone, are the most abused prescription drug in the United States. Drug company Mallinckrodt is seeking approval ... Read More

The type 2 diabetes drug Victoza (liraglutide) can help overweight and obese people without diabetes lose weight, according to a new multinational clinical trial, but the drug comes with some risks. Victoza, an injectable drug in a class of diabetes medications known as glucagonlike peptide-1 (GLP-1) agonist, was approved by the Food and Drug Administration (FDA) in January 2010 to help lower blood sugar levels in people with type 2 diabetes. In an effort to expand the indication to non-diabetics who are overweight, the medication was pitted against a placebo and the currently marketed anti-obesity drug Qsymia, a combination of ... Read More

A new zero-calorie sweetener will soon hit store shelves, giving consumers more sugar substitute options to sweeten or add flavor to their foods, the Food and Drug Administration (FDA) announced. The new sweetener is called advatame, but does not yet have an official brand name. Advatame, along with other marketed sugar substitutes, are called high-intensity sweeteners “because small amounts pack a large punch when it comes to sweetness,” says Captain Andrew Zajac, U.S. Public Health Service (USPHS) director of the Division of Petition Review at the Food and Drug Administration (FDA). Unlike sweeteners like sugar, honey or molasses, high-intensity sweeteners ... Read More

The Food and Drug Administration (FDA) proposed reclassifying transvaginal mesh devices from moderate-risk to high-risk, requiring manufacturers to submit a premarket approval application for the agency to evaluate a device’s safety and efficacy before the device can be approved for marketing. Transvaginal mesh is a type of surgical mesh that is inserted through the vagina to treat common pelvic floor disorders such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh holds up organs that have dropped due to the stress of childbirth, obesity or age, causing symptoms such as incontinence, pain during sexual intercourse, and general discomfort. ... Read More

A Food and Drug Administration (FDA) advisory panel has voted unanimously not to recommend the approval of a powerful new prescription painkiller designed to deliver faster relief with fewer side effects. Moxduo is the first drug to combine morphine and oxycodone in one capsule. It is intended to treat moderate to severe pain, such as that associated with accidents and major surgery. Panel members said the drug’s developer QRxPharma did not adequately prove that Moxduo provides better pain relief than morphine or oxycodone alone, nor that the drug is less likely to cause potentially fatal respiratory depression compared to its ... Read More

Massachusetts governor Deval Patrick’s banning of the controversial new painkiller Zohydro may be the first time a state has tried to block distribution of an FDA-approved drug and sets the stage for a heated constitutional debate. Last week, Gov. Patrick restricted doctors in Massachusetts from prescribing or dispensing Zohydro, the only pure hydrocodone on the market. The medication was approved by the FDA last fall and was distributed nationwide last month. Gov. Patrick banned the drug in an effort to curb a growing prescription drug abuse epidemic. In response, Zohydro’s maker, Zogenix, filed a lawsuit this week in an attempt ... Read More

An advisory committee for the European drug authority is recommending the approval of empagliflozin, a new type 2 diabetes drug made by Boehringer Ingelheim and Eli Lilly and Company. Empagliflozin is in a new class of diabetes drugs known as sodium glucose co-transporter 2, or SGLT-2, inhibitors. It works by targeting glucose directly and works independently of B-cell function and insulin resistance. The drug produces increased urinary glucose excretion, with a consequent lowering of plasma, glucose levels, and weight loss. If approved, the empagliflozin would be marketed under the name Jardiance. Earlier this month, the U.S. Food and Drug Administration ... Read More