Content about U.S. Food and Drug Administration

HAWTHORNE, N.Y. — Taro Pharmaceutical Industries reported last week that it has received approval from the Food and Drug Administration for its new drug application Topicort (desoximetasone) topical spray, 0.25%.

Topicort topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

According to Taro, the corticosteroid spray market is approximately $100 million in annual sales in the United States.

WASHINGTON — The U.S. Food and Drug Administration has approved a new drug from Johnson & Johnson for patients with tuberculosis who do not respond to other treatments, the company announced.

Tuberculosis is an air-spread infection that usually attacks the lungs, but also affect the brain, the spine and the kidneys. The drug blocks an energy-producing enzyme the tuberculosis bacteria needs to survive and is the first drug in 40 years to attempt to cure the disease using this type of treatment.

SPRING SPRING, Md. — The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies.

PITTSBURGH — Mylan on Friday announced that its partner Famy Care has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol tablets USP in the 0.15mg/0.03mg strength.

The product is a generic version of Teva Branded Pharmaceutical Products' Nordette 28 Tablets, a form of oral contraception. The new product will be distributed in the United States by Mylan Pharmaceuticals, and the company is shipping the product immediately.

SAN DIEGO — Regional life sciences association Biocom has introduced a new eco-friendly alternative to sanitary napkins and tampons. Enter FemmyCycle, a product from member FemCap.

The FemmyCycle was granted clearance by the U.S. Food and Drug Administration on Nov. 16. FemmyCycle creator Alfred Shihata is familiar with developing feminine products. His FDA-approved FemCap is one of the few hormone-free, woman-controlled contraceptive methods available.

ALLEGAN, Mich. — Perrigo has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application to market over-the-counter omeprazole and sodium bicarbonate capsules in the 20-mg/1,100-mg strength, the store-brand equivalent to Merck's Zegerid OTC.

Zegerid OTC (omeprazole and sodium bicarbonate capsules 20 mg/1,100 mg), a proton-pump inhibitor indicated to relieve frequent heartburn, had sales of approximately $42 million through food, drug and mass merchandisers for the lastest 12 months.

WASHINGTON — A panel of outside advisers to the Food and Drug Administration has backed wider use for Abbott Labs’ rheumatoid arthritis drug, Humira, for treating a type of inflammatory bowel disease.

According to published reports, the panel voted 15-2 that the benefits of Humira outweighed the risks in treating ulcerative colitis. However, the panel asked Abbott to conduct more studies upon Humira's approval.

WASHINGTON — The Personal Care Products Council and the Safe Cosmetics Alliance has announced support for legislation to strengthen and modernize regulatory oversight of the industry and to create a greater role for the Food and Drug Administration in assessing the safety of personal care products.