FDA Approves Cuvposa (glycopyrrolate) for Chronic Drooling in Children

Aug 9th of 2010

Drugs Nervous System Musculoskeletal FEATURED

The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years. Drooling is normal in infants. But a significant proportion of the developmentally disabled population experiences drooling caused primarily by neuromuscular dysfunction that makes it hard to swallow. Cuvposa reduces drooling by lowering the volume of saliva produced.

FDA Approves Vaccines for the 2010-2011 Influenza Season

Aug 3rd of 2010

Drugs Cold and Flu Immunology FEATURED BREAKING

The U.S. Food and Drug Administration announced today that it has approved vaccines for the 2010-2011 influenza season in the United States. Seasonal influenza vaccine protects against three strains of influenza, including the 2009 H1N1 influenza virus, which caused the 2009 pandemic.

FDA Approves First Generic Enoxaparin Sodium Injection to Prevent Deep Vain Thrombosis

Jul 23rd of 2010

Drugs Cardiovascular Blood & Lymphatic

The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis (DVT), a potentially deadly blood clotting condition.

FDA Approves First Generic Effexor Extended Release Capsules to Treat Major Depressive Disorder

Jun 29th of 2010

Drugs Depression Mental Health

On June 28, the U.S. Food and Drug Administration approved the first generic version of Effexor XR capsules (venlafaxine hydrochloride) to treat major depressive disorder. Venlafaxine hydrochloride extended-release capsules in 37.5 milligram, 75 milligram and 150 milligram strengths have been approved to be manufactured by TEVA Pharmaceuticals, North Wales, Pa.

FDA Approves First Diagnostic Assay to detect both HIV Antigen and Antibodies

Jun 21st of 2010

Drugs HIV/AIDS Immunology FEATURED

The U.S. Food and Drug Administration today approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.

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FDA Approves New Treatment Jevtana (cabazitaxel) for Advanced Prostate Cancer

Jun 18th of 2010

Drugs Prostate Cancer FEATURED BREAKING

The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.

FDA Approves New Indication for Tasigna (nilotinib)

Jun 18th of 2010

Drugs Blood & Lymphatic Leukemia FEATURED

The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women

Jun 1st of 2010

Drugs Musculoskeletal Osteoporosis FEATURED

The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

FDA: Possible Fracture Risk with High Dose, Long-term Use of Proton Pump Inhibitors

May 26th of 2010

Drugs Gastrointestinal GERD (Acid Reflux) FEATURED BREAKING

The U.S. Food and Drug Administration today warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.

FDA Approves Natazia - A New Combination Product Oral Contraceptive

May 7th of 2010

Drugs Sexual & Reproductive Pregnancy

The U.S. Food and Drug Administration today approved Natazia, a combination hormonal tablet for use as an oral contraceptive. Natazia contains two female hormones, an estrogen (estradiol valerate) and a progestin (dienogest), and is the first four-phasic oral contraceptive marketed in the United States. Four-phasic refers to the doses of progestin and estrogen varying at four times throughout each 28-day treatment cycle.