Selected products with Phase III or regulatory milestones expected in 4Q13. (A) PDUFA date estimated based on eight-month Priority Review; Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

Acorda Therapeutics Inc. (NASDAQ:ACOR)

Diazepam nasal spray

Acute repetitive seizures in patients with epilepsy

Submit NDA

4Q13

Actelion Ltd. (SIX:ATLN)

Opsumit macitentan

Pulmonary arterial hypertension (PAH)

PDUFA date

10/19/13

Alimera Sciences Inc. (NASDAQ:ALIM)/pSivida Corp. (NASDAQ:PSDV; ASX:PVA)

Iluvien fluocinolone acetonide

Diabetic macular edema (DME)

PDUFA date

10/17/13

Almirall S.A. (Madrid:ALM)/Menarini Group

Aclidinium bromide/ formoterol fumarate

Chronic obstructive pulmonary disease (COPD)

Submit MAA

4Q13

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG)

Rienso ferumoxytol

Iron deficiency anemia in adult patients who have failed or otherwise cannot take oral iron therapy

PDUFA date

10/21/13

Amarin Corp. plc (NASDAQ:AMRN)

Vascepa icosapent ethyl

Adults with high triglycerides with mixed dyslipidemia

FDA panel; PDUFA date

10/16/13; 12/20/13

Amgen Inc. (NASDAQ:AMGN)/Bayer AG (Xetra:BAYN)

Nexavar sorafenib

Locally advanced or metastatic, radioactive iodine-refractory, differentiated thyroid cancer

PDUFA date

12/25/13

Antares Pharma Inc. (NASDAQ:ATRS)

Otrexup methotrexate

Rheumatoid arthritis (RA)

PDUFA date

10/14/13

Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL)/BioSpecifics Technologies Corp. (NASDAQ:BSTC)

Xiaflex collagenase clostridium histolyticum

Peyronie's disease

PDUFA date

12/6/13

Bayer AG (Xetra:BAYN)

Adempas riociguat

PAH and inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent/recurrent CTEPH after pulmonary endarterectomy

PDUFA date

10/8/13