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BAYER HEALTHCARE LLC: Aleve PM NDA #205352

Aleve PM is the first and only over-the-counter (OTC) PM product with the 12-hour pain-relieving strength of Aleve plus a sleep aid. Each caplet combines the sleep aid diphenhydramine HCl (25 mg) with the pain reliever naproxen sodium (220 mg), a nonsteroidal anti-inflammatory drug, to provide relief from occasional sleeplessness associated with minor aches and pains. It can help you fall asleep and stay asleep.

Measles cases in U.S. hit 465 so far this year, CDC reports

The number of U.S. measles cases confirmed this year as of April 4 reached 465, the second-highest level for any year since the nation declared the disease eliminated in 2000, according to the Centers for Disease Control and Prevention.

U.S. FOOD AND DRUG ADMINISTRATION: Agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

U.S. FOOD AND DRUG ADMINISTRATION: FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices

The U.S. Food and Drug Administration ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately.

Female hypoactive sexual desire disorder drug Addyi to have labeling updated on mixing with alcohol

A labeling change order was issued to Sprout Pharmaceuticals last week by the Food and Drug Administration concerning its drug Addyi (flibanserin).

ONCOLOGY MANAGERS OF FLORIDA, INC.: Urges Policymakers to Oppose Drug Importation Proposals

Encourages Florida Policymakers to Consider Alternatives to Rising Out-of-Pocket Costs

Fiscal year 2019 FDA medical device fees released

Fee rates and payment instructions for companies submitting new medical device applications to the federal Food and Drug Administration have been released for fiscal year 2019, which began on Oct. 1, 2018.

Research group calls for a moratorium on opioid production and asks for FDA's Woodcock to step down

Health research group Public Citizen's founder, Sidney Wolfe, believes a moratorium on opioid production is necessary because new opioids and reformulations of opioids have more known risks than benefits.

FDA assesses duoenoscope contamination risk

The Food and Drug Administration oversees manufacturers’ postmark surveillance studies on new and significant health concerns in order to understand a device’s risks and to update policies on such risks.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first generic naloxone nasal spray to treat opioid overdose

Agency is also taking new steps to support development of over-the-counter and additional generics of naloxone to help reduce opioid overdose deaths, increase access to emergency treatment

FDA could be prohibiting terminal patients from life-saving treatments and medication

The world of pharmaceuticals and biotechnology is ever-growing and changing, but seemingly only behind closed doors.

CIRCASSIA PHARMACEUTICALS, INC.: US Food and Drug Administration Approves DUAKLIR® PRESSAIR® (aclidinium/formoterol) for Patients with Chronic Obstructive Pulmonary Disease (COPD)

Circassia Pharmaceuticals Inc. (“Circassia” or “the Company”), today announced that the US Food and Drug Administration has approved DUAKLIR® PRESSAIR® (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Corey Polen battles for right to receive ALS medication

Corey Polen was a healthy 40-year-old man enjoying his life with his wife and three children. In October of 2015 that all changed when he started feeling spurts of weakness, not thinking too much about it until it began to progress rapidly with no answers.

FDA Reporter