FDA tentatively approves Sun’s generic Cymbalta
MUMBAI, India — A generic drug maker announced that the Food and Drug Administration has granted tentative approval for its version of a popular antidepressant.
Sun Pharmaceutical Industries said the FDA approved its duloxetine hydrochloride delayed-release capsules in 20-mg, 30-mg and 60-mg strengths. The capsules are a generic version of Eli Lilly’s Cymbalta, which is indicated to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain.
Cymbalta has been sold in the United States since 2004.
CVS/pharmacy hopes to boost flu shot rates among African-Americans
NEW YORK — CVS/pharmacy is encouraging African-Americans to get a seasonal flu shot as African-Americans have lower influenza and pneumococcal immunization rates, compared with the rest of the population.
According to CVS/pharmacy, 67% of whites received flu shots in the past year, compared with 48% of African-Americans and 55% of Hispanics. The CVS/pharmacy "all-in-one" flu shot protects against three of this season’s flu viruses, including H1N1 and the new strain H3N2. With the majority of influenza cases that can be prevented by receiving the flu vaccine, it is best to get a flu vaccination as early as possible. The CVS/pharmacy "all-in-one" flu shots are $29.95 and are covered by many insurance plans.
African-Americans have many misconceptions about getting the flu shot and do not realize that the seasonal flu can be unpredictable and even healthy people can get seriously ill from the flu, according to CVS/pharmacy.
Approximately 75% of all influenza and pneumonia deaths in African-Americans occur among those ages 65 years and older. Many also believe that if they get the flu shot, they will get seriously ill. It is even thought among African-Americans that the flu shot administered in retail settings is not of the same quality and standard as the flu shot from their doctor’s office. None of these myths are true, the retailer stated.
"[The Centers for Disease Control and Prevention’s] new universal recommendation was expanded this year to encourage anyone 6 months of age or older to get a flu shot," explained Ian Smith, medical expert and CVS/pharmacy spokesperson. "The CVS/pharmacy ‘all-in-one’ flu shot is a convenient way to get protected against the flu and a great gift this holiday season to yourself and your loved ones. It is administered by licensed CVS pharmacists and MinuteClinic nurse practitioners and it is the same flu shot that you would get from your doctor."
CVS/pharmacy also is offering flu shot gift cards for $29.95.
FDA review of MS drug extended, EMD Serono says
ROCKLAND, Mass. — The Food and Drug Administration has extended its review period for a multiple sclerosis drug made by EMD Serono, the drug maker said Friday.
EMD Serono — the U.S. subsidiary of German drug maker Merck KGaA, which uses the name to avoid confusion with U.S.-based Merck — said the FDA had extended the review time for cladribine tablets to Feb. 28. The drug is a disease-modifying drug for relapsing MS.
The FDA gave the drug an expedited review period in July, reducing the standard 10-month review period to six months. EMD said the FDA extended the review period to give it more time for a full review of additional information included in the regulatory application.