Generics
US FDA grants tentative approval to Impax Laboratories for generic version of Coreg CR
11 December 2017 -

The United States Food and Drug Administration (FDA) has granted tentative approval to Impax Laboratories Inc (NASDAQ: IPXL), a specialty pharmaceutical company, for its Abbreviated New Drug Application (ANDA) for the generic version of Coreg CR (carvedilol phosphate) extended-release capsules, 10, 20, 40 and 80 mg, it was reported on Friday.

The Company's ANDA is eligible for final approval upon the expiration of marketing exclusivity on 7 May 2018.

According to IMS Health, for the 12 months ending October 2017, the product had United States brand sales of around USD206m.

Login
Username:

Password: