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FDA actions in brief

Article

Budesonide/formoterol (Symbicort, AstraZeneca) was approved as maintenance therapy for asthma in patients aged 12 years and older.

Budesonide/formoterol (Symbicort, AstraZeneca) was approved as maintenance therapy for asthma in patients aged 12 years and older.

FDA approved levetiracetam injection 500 mg/5 mL (100 mg/mL) (Keppra, UCB Group) as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The drug was previously approved in tablet and oral solution formulations as adjunctive therapy to treat partial-onset seizures in patients aged 4 years and older with epilepsy.

Levonorgestrel 0.75-mg tablets (Plan B, Barr) were approved for over-the-counter (OTC) sale to prevent pregnancy in women aged 18 years and older following unprotected intercourse or a known or suspected contraceptive failure. The product will remain available by prescription only for women aged 17 years and younger.

Ketoconazole 2% gel (Xolegel, Barrier Therapeutics) was approved for the topical treatment of seborrheic dermatitis in immunocompetent patients aged 12 years and older.

FDA approved adalimumab (Humira, Abbott) for reducing the signs and symptoms of active ankylosing spondylitis.

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