Prescription Drugs

Drug Labeling Puts People With Vision Loss At Medical Risk

Would you feel safe taking a dose of medication if you were not fully confident you were taking the correct amount? What would you do if you couldn’t read important drug information on prescription bottles or package inserts? For the more than 20 million people living with vision loss, not being able to read drug [...]

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FDA Improves Safety Of Drugs, Active Drug Ingredients

The U.S. Food and Drug Administration today announced the launch of a voluntary pilot program that would help promote the safety of drugs and active drug ingredients produced outside the United States. The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to meet [...]

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Novel Vaccines Improve Potential For European Vaccines Manufacturers

The vaccines market, which was earlier associated with low profit margins and slow growth rates, has gained momentum in recent years through innovation. The introduction of novel vaccines for diseases with high burden and continuous investments aimed at boosting production capacity is driving the growth of this previously unattractive market. New analysis from Frost %26amp; [...]

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Tramadol Added To Kentucky Prescription Drug Monitoring System

The Cabinet for Health and Family Services Office of Inspector General (OIG) is increasing efforts to monitor the types and amounts of potentially addictive prescription drugs dispensed to Kentuckians, recently becoming only the second state to add the drug Tramadol to its list of controlled substances. Tramadol, which is intended to alleviate pain, has been [...]

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FDA Approves Savella For Fibromyalgia Management

Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) today announced that Savella (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia. Fibromyalgia is a chronic condition characterized by widespread pain and decreased physical function, afflicting as [...]

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Atypical Antipsychotic Drug Increases Risk Of Sudden Cardiac Death

Patients ages 30 to 74 who took atypical antipsychotics such as risperidone (sold as Risperdal), quetiapine (Seroquel), olanzapine (Zyprexa) and clozapine (Clozaril) had a significantly higher risk of sudden death from cardiac arrhythmias and other cardiac causes than patients who did not take these medications, according to a new study funded by HHS’ Agency for [...]

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PEGASYS Proven Effective As Hepatitis C Treatment

Results from the LATINO study, the largest study conducted to-date in Latino patients with the hepatitis C virus (HCV), were published today in The New England Journal of Medicine (NEJM). This Roche study demonstrated that HCV can be successfully treated among Latino patients, a patient population that is historically difficult to treat. The study, “Peginterferon [...]

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FDA Asks For Warning For Epilepsy Drugs

FDA is going to request a ‘black box’ warning for all epilepsy drugs, because of the risk for suicidal thoughts and inadequate behavior. An advisory panel of outside experts will discuss the request from FDA on Thursday about the black box warning, which is the strongest warning ever. FDA asks for the warning on every [...]

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New Injectable Collagen Filler Offers Natural Results

SKINTASTIC Medical and Surgical Rejuvenation Center is pleased to announce the arrival of newly FDA-approved EVOLENCE — the latest injectable collagen filler in the Skintastic arsenal of little-or-no-downtime beauty treatments. EVOLENCE boasts immediate, predictable visible results, with little swelling. Less bruising and pain were also reported with EVOLENCE in a comparison study against a popular [...]

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Ratio-Morphine Tablets Recalled In Canada

Health Canada is warning consumers not to use the prescription drug ratio-Morphine SR in 15 milligram (mg), 30 mg, and 60 mg formats. Some tablets may contain more morphine than the label indicates, exposing patients to the potential risk of accidental overdose. Oversized tablets that are noticeably thicker than the regular tablets, and which may [...]

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FDA Revises Process For Responding To Drug Applications

FDA is now revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Under new regulations that govern the drug approval process, FDA’s Center for Drug Evaluation and Research (CDER) will no longer issue “approvable” or “not approvable” letters when a drug application is not approved. Instead, CDER [...]

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FDA Requests Boxed Warnings On Fluoroquinolone Antimicrobial Drugs

FDA has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs [...]

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