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.
IPC's lead products in the generic, controlled-release pharmaceutical category are Dexmethylphenidate XR (dexmethylphenidate hydrochloride), a generic version of Focalin XR, which is an extended-release capsule for the treatment of Attention Deficit Hyperactivity Disorder, and Carvedilol CR (carvedilol phosphate), a generic version of Coreg CR
, which is an extended release capsule for the treatment of high blood pressure.
will utilize Flamel's proprietary Micropump[R] technology, which controls the delivery of carvedilol helping to maintain appropriate amounts of medicine in the body over a 24-hour span.
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 drug is a generic version of GSK's (NYSE: GSK) Coreg CR
Product sales and services during the fourth quarter of 2011, related primarily to production of Coreg CR
microparticles, were $4.
Drug delivery company Flamel Technologies (Nasdaq:FLML) revealed on Tuesday that it has signed a multi-year supply agreement with GlaxoSmithKline (NYSE:GSK) for the production of Coreg CR
Recent highlights include completion of new Coreg CR
Supply Agreement; License and Development Agreement with Eagle Pharmaceuticals
LYON, France -- Flamel Technologies (Nasdaq: FLML) announced today that it has entered into a multi-year supply agreement with GlaxoSmithKline (NYSE: GSK) for the production of Coreg CR
Flamel continues to work to protect its technology and Coreg CR
The lawsuit is based on the Abbreviated New Drug Application (ANDA) filed by Lupin seeking permission to manufacture and market a generic version of Coreg CR
before the expiration of the patent.
Flamel also announced today that it has received a Paragraph IV certification letter from Lupin Pharmaceuticals with respect to Coreg CR
[R] and the Flamel patent listed in the Orange Book regarding the use of the Micropump platform for Coreg CR
that it has licensed to Glaxo SmithKline (GSK).
Flamel and GSK are in negotiations for a new supply agreement for Coreg CR
following the expiration of the old supply agreement on December 31, 2010; Flamel expects that these will be successful.
Flamel Receives FDA Response Letter Regarding Coreg CR
Other revenues in the first quarter, consisting primarily of royalty revenues from GSK related to sales of Coreg CR
, were $2.