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Weekly Drug News Round Up - April 10, 2013

Diclegis Oral Tablet Approved for Morning Sickness

Diclegis is now the only FDA-approved treatment for nausea and vomiting due to pregnancy Read More...

The U.S. Food and Drug Administration (FDA) have approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat women experiencing pregnancy-related nausea and vomiting. Diclegis is a delayed-release tablet for women who have not responded to conservative dietary or lifestyle management of “morning sickness” -- the nausea and vomiting that often occurs in early pregnancy. Diclegis was previously on the U.S. market as Bendectin, but was removed 30 years ago due to safety concerns. According to the FDA, the drug has undergone rigorous scrutiny and is now deemed safe for the fetus. Side effects in women can include drowsiness. Launch of Diclegis is expected in June 2013.

Court Orders “Morning-After Pill” Available OTC for All Women

Currently, girls 16 years and younger need a prescription to get the emergency contraceptive pill Read More...

A federal judge from the state of New York has ordered the U.S. Food and Drug Administration (FDA) to make the emergency contraceptive pill available to all women over-the-counter (OTC) regardless of age. The FDA has 30 days from the date of the order to remove age restrictions on the sale of over-the-counter emergency contraception, such as Plan B One-Step, Next Choice and Next Choice One Dose. In 2011, Kathleen Sebelius, U.S. Health and Human Services Secretary, overruled a FDA proposal to make the drug available to all women over-the-counter. The FDA has stated that it has scientific evidence that Plan B One-Step is a safe and effective way to prevent unintended pregnancy.

Karbinal ER Oral Suspension Approved for Seasonal and Year-Round Allergies

Karbinal ER is a sedating antihistamine that may be useful for patients who have no success with non-sedating antihistamines Read More...

Karbinal ER (carbinoxamine maleate) extended-release oral suspension is a first generation H1-receptor antagonist indicated to treat the symptoms of seasonal and perennial (year-round) allergic rhinitis. Karbinal ER is the first sustained-release antihistamine approved for the treatment of allergic rhinitis in children ages 2 and over. The antihistamine, dosed twice daily, is also indicated as an oral treatment for allergic conjunctivitis (eye allergy), as an adjunct to severe allergic reactions, and for allergic urticaria (itching). Tris Pharma plans to launch Karbinal ER prior to the fall allergy season.

Prolensa: Approved to Treat Eye Pain and Swelling After Cataract Surgery

Nearly four of five patients treated with Prolensa were pain free at day one Read More...

Prolensa (bromfenac ophthalmic solution), a prescription nonsteroidal anti-inflammatory drug (NSAID) eye drop, has been approved for the treatment of postoperative swelling and pain in patients who have undergone cataract surgery. The dosage for Prolensa is one drop into the affected eye once daily beginning the day prior to surgery, then continued on the day of surgery and through the first 14 days post surgery. Bausch + Lomb’s Prolensa does not require shaking of the bottle to deliver a consistent dose. Other bromfenac eye solutions available on the U.S. market include the once-a-day Bromday, and the generic bromfenac ophthalmic solution, instilled into the eye twice a day.

Few Medicare Beneficiaries Are Receiving Shingles Vaccine

Researchers collected data from more than 766,000 Medicare seniors between 2007 and 2009 Read More...

Shingles, also known as herpes zoster, occurs when the chickenpox virus in nerve cells becomes active again later in life and causes an often painful skin rash. New research suggests that U.S. seniors are skipping the vaccine that is available to help prevent shingles (Zostavax). They found that the vaccine reduced the rate of shingles by 48 percent and the rate of the painful shingles-related complication called post-herpetic neuralgia by 59 percent. Despite its effectiveness, less than 4 percent of the seniors (roughly 30,000 out of 766,000) had received the vaccine; rates of vaccination were especially low among blacks and those with low income.