New Products

PITTSBURGH — Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and rizatriptan benzoate tablets, 5 mg and 10 mg. These products are the generic versions of Merck's Maxalt MLT® Tablets and Maxalt® Tablets, respectively, and are indicated for the acute treatment of migraine with or without aura in adults.

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.

AUSTIN, Texas — To meet growing consumer demand for healthier choices, Whole Foods Market is introducing Engine 2 Plant-Strong products, a new line of plant-based, minimally processed snacks, breakfast items and pantry staples. Developed in collaboration with Rip Esselstyn, author and founder of The Engine 2 Diet, the products will be available exclusively at Whole Foods Market stores nationwide beginning January 2013.

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.

NEW YORK — DevaCurl — a hair care brand designed exclusively for curly, wavy and chemically processed hair — has created the DevaCurl No-Comb Detangling Spray to untangle, fortify and revitalize dry, damaged and frizz-prone curls while restoring moisture balance. 

 PITTSBURGH — Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.

The product is a generic version of Pfizer's Dilantin Chewable Tablets, which are indicated for the control of generalized tonic-clonic (i.e., grand mal) and complex partial (i.e., psychomotor, temporal lobe) seizures, and prevention and treatment of seizures occurring during or following neurosurgery.

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.

PARSIPPANY, N.J. — Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the U.S. Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

Bortezomib is a proteasome inhibitor for intravenous or subcutaneous administration, approved for treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.