Selected products up for approval in 2014. (A) PDUFA based on standard 10-month review; (B) PDUFA based on 6-month priority review; Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

Zalviso sufentanil sublingual microtablet system

Manage moderate to severe acute pain in a hospital setting

PDUFA date

July

Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS)

Macimorelin acetate

Diagnose adult growth hormone deficiency

PDUFA date

11/5/14

Alfa Wassermann S.p.A./Salix Pharmaceuticals Inc. (NASDAQ:SLXP)

Rifaximin

Diarrhea-predominant irritable bowel syndrome (IBS-D)

FDA action

2H14

ALK-Abello A/S (CSE:ALK-B)/Merck & Co. Inc. (NYSE:MRK)

Grastek grass pollen Allergy Immunotherapy Tablet (AIT)

Timothy grass pollen-induced allergic rhinitis with or without conjunctivitis

FDA action

1H14

ALK-Abello A/S (CSE:ALK-B)/Merck & Co. Inc. (NYSE:MRK)

Ragwitek ragweed Allergy Immunotherapy Tablet (AIT)

Ragweed-induced allergic rhinitis with or without conjunctivitis

FDA panel; FDA action

1/28/14; 1H14

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG)

Feraheme ferumoxytol

Adult patients with iron deficiency anemia who have failed or could not tolerate oral iron treatment

PDUFA date

1/21/14

Anacor Pharmaceuticals Inc. (NASDAQ:ANAC)

Tavaborole

Onychomycosis

PDUFA date

7/29/14