Beyaz

Beyaz

Generic Name: drospirenone, ethinyl estradiol and levomefolate calcium

Date of Approval: September 24, 2010

Company: Bayer HealthCare Pharmaceuticals Inc.

Treatment for: Birth Control, Premenstrual Dysphoric Disorder, Acne

FDA Approves Beyaz

The U.S. Food and Drug Administration (FDA) has approved Beyaz, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg).

Beyaz is based on the approved product Yaz, which contains the same doses of estrogen and progestin, and is approved for prevention of pregnancy, premenstrual dysphoric disorder and the treatment of moderate acne vulgaris in women at least 14 years of age, only if the patient desires an oral contraceptive for birth control. Beyaz also is approved for the secondary indication in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

Gadavist

Gadavist

Generic Name: gadobutrol

Date of Approval: March 14, 2011

Company: Bayer HealthCare Pharmaceuticals Inc.

Treatment for: Diagnostic Magnetic Resonance Imaging

FDA Approves Gadavist

The U.S. Food and Drug Administration has approved Gadavist (gadobutrol) Injection, a macrocyclic gadolinium-based contrast agent (GBCA), for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system (CNS).

Highlights of Gadavist Prescribing Information

Human Secretin

Human Secretin

Generic Name: Secretin Synthetic Human

Company: ChiRhoClin, Inc.

Treatment for: Secretin Stimulation Testing

FDA approves Human Secretin

The Food and Drug Administration, Center for Drug Evaluation and Research, Office of Drug Evaluation has issued ChiRhoClin, Inc. an approval for Human Secretin.

The FDA has approved three indications. The indications of Human Secretin are the following:

Stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction.

Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma, and

Hydrochlorothiazide

hydrochlorothiazide

Generic Name: hydrochlorothiazide (hye dro klor o THY a zide)

Brand names: Aquazide H, HydroDIURIL, Microzide

What is hydrochlorothiazide?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Hydrochlorothiazide treats fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or kidney disorders, or edema caused by taking steroids or estrogen. This medication is also used to treat high blood pressure (hypertension).

Hydrochlorothiazide may also be used for other purposes not listed in this medication guide.

Istodax

Istodax

Generic Name: romidepsin (ROE mi DEP sin)

Brand Names: Istodax

What is Istodax?

Istodax blocks certain enzymes in the body and interferes with the growth of tumor cells.

Istodax is used to treat T-cell lymphoma affecting the skin (cutaneous T-cell lymphoma, or CTCL).

Istodax is usually given after other medications have been tried without successful treatment of symptoms.

Istodax may also be used for other purposes not listed in this medication guide.

Important information about Istodax

Before you receive Istodax, tell your doctor if you have an electrolyte imbalance, a personal or family history of "Long QT syndrome," heart disease, kidney disease, or liver disease.

Menostar

Menostar

Generic Name: estradiol transdermal (ess tra DYE ol tranz DERM al)

Brand Names: Alora, Climara, Estraderm, Estradiol Patch, Menostar, Vivelle, Vivelle-Dot

What is Menostar?

Menostar is a skin patch that contains estradiol, a form of estrogen. Estradiol is a female sex hormone the regulates many processes in the body.

Menostar skin patches are used to prevent postmenopausal osteoporosis. Menostar skin patches release estradiol slowly, and it is absorbed through your skin. They are used to provide the female hormone when the body no longer produces enough.

Menostar may also be used for other purposes not listed in this medication guide.

Methadone

Methadone

Generic Name: methadone (METH a done)

Brand Names: Diskets, Dolophine, Methadose

What is methadone?

Methadone is a narcotic pain reliever, similar to morphine. It also reduces withdrawal symptoms in people addicted to heroin or other narcotic drugs without causing the "high" associated with the drug addiction.

Methadone is used as a pain reliever and as part of drug addiction detoxification and maintenance programs.

Methadone may also be used for purposes other than those listed in this medication guide.

Important information about methadone

Taking methadone improperly will increase your risk of serious side effects or death. Even if you have used other narcotic medications, you may still have serious side effects from methadone. Follow all dosing instructions carefully.