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FDA Approves New Type of Sleep Medication

The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).

Rare Risk of Long-Lasting Erections from ADHD Medications

FDA is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism.

Cymbalta Goes Generic

The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.

FDA Approves New Drug to Treat Major Depressive Disorder

The US Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.

FDA Permits Marketing Test to Help Assess Children and Teens for ADHD

The US Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old.

FDA Investigating Two Deaths Following Injection of Zyprexa Relprevv

The US Food and Drug Administration (FDA) is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate).

Nicotine Replacement Therapy Labels May Change

When nicotine replacement therapy (NRT) products were first marketed almost 30 years ago to help people stop smoking, there wasn't a lot of data available on how long consumers could safely use them, and whether they could be used in combination with other NRTs or with continued smoking.

FDA Drug Safety Communication: Chantix Heart Risk

The US Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.

FDA Approves Generic Singulair

The U.S. Food and Drug Administration approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.

FDA Warning: Counterfeit Adderall

The U.S. Food and Drug Administration is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet.