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news.Pennsylvania-based generics firm Lannett Company has received approval from the FDA for its abbreviated new drug application for terbutaline sulfate tablets, the generic equivalent of Novartis and aaiPharma's Brethine, used for the treatment of asthma and bronchitis.
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Lannett has now been approved to market 2.5mg and 5mg doses of terbutaline sulfate tablets, making the company the second generic supplier approved to market a copycat version of Brethine.
Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm (a narrowing of the airways) in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
“We are pleased that our product development efforts are beginning to pay dividends with our first product approval thus far in 2005,” said Arthur Bedrosian, president of Lannett. “With ten product applications currently pending at the FDA, we look forward to additional approvals this year, further building our product offering.”
Lannett expects to begin marketing the product shortly.