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news.Breckenridge Pharmaceutical and Aptalis Pharmatech have signed an agreement to market propranolol hydrochloride extended-release capsules, USP the generic version of Akrimax Pharmaceuticals's Inderal LA, under Aptalis's abbreviated new drug application.
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On 15 July 2011, the US Food and Drug Administration (FDA) had approved the product.
As part of the agreement, Aptalis will produce and supply the product to Breckenridge who will have exclusive marketing and distribution rights in the US.
Propranolol hydrochloride extended-release capsules are used to treat hypertension, angina pectoris due to coronary atherosclerosis, migraine, and hypertrophic subaortic stenosis.
Based on industry sales data, the current generic market is approximately $75m.
The generic capsules are available in four strengths as 60mg, 80mg, 120mg and 160mg.
The companies have already commenced the shipping the product.