Algeta ASA and partner Bayer AG disclosed FDA approval Wednesday for Xofigo (radium Ra 223 dichloride) in castration-resistant prostate cancer, with the agency's nod coming three months ahead of the Aug. 14 PDUFA date

It has a Dec. 18 PDUFA date and is also under review in Europe

Anoro Ellipta, a LAMA/LABA combo product from the collaboration between GSK and Theravance Inc. – recently approved Breo Ellipta, a combination LABA and inhaled corticosteroid, emerged from that same alliance – is currently under FDA review, with a Dec. 18 PDUFA date. (See BioWorld Today, May 13, 2013.)

It has a Dec. 18 PDUFA date and is also under review in Europe

Earlier this month, Alimera resubmitted the new drug application for Iluvien, which has a PDUFA date of Oct. 17

While we are disappointed with the outcome of the ODAC vote, we remain confident in the efficacy, safety and tolerability of tivozanib in RCC patients," he said, adding that AVEO will work closely with the FDA to address the issues raised by the panel ahead of the drug's July 28 PDUFA date

Burrill Institutional Research analyst Elemer Piros suggested following the adcom that Probuphine's PDUFA date might be extended by three months to tweak the REMS program

The FDA put some lift under the wings of Raptor Pharmaceutical Corp., approving the orphan drug Procysbi (RP103, cysteamine bitartrate delayed-release) on its PDUFA date in the initial indication of nephropathic cystinosis (NC

Even though the market is crowded with competitors like Nexavar, Sutent (sunitinib, Pfizer Inc.), Torisel (temsirolimus, Pfizer Inc.) and Votrient (pazopanib, GlaxoSmithKline plc), AVEO hoped to clean up by positioning tivozanib as a best-in-class option. (See BioWorld Today, Feb. 17, 2011.) Looking beyond tivozanib's July 28 PDUFA date for the advanced RCC indication, AVEO is developing the drug for other cancers

The PDUFA date is May 12. (See BioWorld Today, April 18, 2013.) According to the company, Theravance Biopharma will be capitalized with approximately $300 million at separation, which is expected to fund operations through significant potential corporate milestones over two to three years

Breo's PDUFA date is May 12

The transaction valued the company at approximately $958 million. (See BioWorld Today, Jan. 24, 2013.) The deal provided Allergan access to MAP's Levadex, an orally inhaled formulation of the intravenous migraine drug dihydroergotamine (DHE), which is under FDA review in acute migraine with a PDUFA date of April 15

The FDA approved the synthetic guanylate cyclase C agonist in August 2012 ahead of its PDUFA date, as a treatment for irritable bowel syndrome with constipation and for chronic constipation

The product was granted priority review for maintenance treatment of opioid dependence in adults with a PDUFA date of April 30

QRxPharma Ltd., of Sydney, Australia, said the FDA set a PDUFA date of Aug. 26 for the resubmitted new drug application seeking approval of Moxduo, an immediate-release dual opioid pain therapy that combines morphine and oxycodone

QRxPharma Ltd., of Sydney, Australia, said the FDA set a PDUFA date of Aug. 26 for the resubmitted new drug application seeking approval of Moxduo, an immediate-release dual opioid pain therapy that combines morphine and oxycodone

and Relvar in Europe, has a PDUFA date of May 12

The PDUFA date for the sNDA is Oct. 21

The FDA will consider the adcom's recommendation when it reviews Sefelsa, which has a May 31 PDUFA date