Government

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Teva's NDA for albuterol MDPI accepted by FDA

Teva Pharmaceuticals on Monday announced that the Food and Drug Administration has accepted the company's new drug application for albuterol multi-dose dry-powder inhaler, a breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease.

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FDA approves Anacor's antifungal solution

Anacor Pharmaceuticals announced that the Food and Drug Administration has approved the company's new drug application for Kerydin (tavaborole) topical solution, 5% — an antifungal approved for the topical treatment of onychomycosis of the toenails.

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Prescribers weigh-in on proposed label rule

A survey co-released by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that 8-in-10 healthcare providers have serious concerns about a proposed Food and Drug Administration rule on generic drug labeling.