Impax Laboratories Inc (NASDAQ:IPXL) reported on Friday the receipt of US Food and Drug Administration (FDA) tentative approval for its Abbreviated New Drug Application (ANDA) for the generic version of Coreg CR (carvedilol phosphate) extended-release capsules in 10, 20, 40 and 80 mg.
Following expiration of marketing exclusivity on 7 May 2018, the company's ANDA is eligible for final approval by the US FDA.
For the 12 months ending October 2017, the company's carvedilol phosphate extended-release capsules had US brand sales of approximately USD206m, according to IMS Health.
The specialist pharmaceutical company is applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products.
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