Selected products up for approval in 2013. Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

Actelion Ltd. (SIX:ATLN)

Opsumit macitentan

Pulmonary arterial hypertension (PAH)

PDUFA date

October

Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR)

Juxtapid lomitapide

Homozygous familial hypercholesterolemia (hoFH)

MAA action

Mid-2013

Alexza Pharmaceuticals Inc. (NASDAQ:ALXA)

Adasuve Staccato loxapine

Schizophrenia or bipolar disorder

MAA action

1Q13

Arena Pharmaceuticals Inc. (NASDAQ:ARNA)/ Eisai Co. Ltd. (Tokyo:4523; Osaka:4523)/ Ildong Pharmaceutical Co. Ltd.(KSE:000230)

Belviq lorcaserin

Chronic weight management

MAA action

1H13

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO)/ Astellas Pharma Inc. (Tokyo:4503)/ Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151)

Tivopath tivozanib

Renal cell carcinoma (RCC)

PDUFA date

7/28/13

Bavarian Nordic A/S (CSE:BAVA)

Imvanex vaccine

Prevent smallpox infection

MAA action

2013

Bayer AG (Xetra:BAYN)/Onyx Pharmaceuticals Inc. (NASDAQ:ONXX)

Regorafenib

Metastatic and/or unresectable gastrointestinal stromal tumors (GIST)

PDUFA date

1Q13

Biogen Idec Inc. (NASDAQ:BIIB)

BG-12

Multiple sclerosis (MS)

PDUFA date

Early 2013

BioMimetic Therapeutics Inc. (NASDAQ:BMTI)

Augment Bone Graft

Alternative to the use of autograft in foot and ankle fusions

PMA action

2013

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

Xiaflex collagenase clostridium histolyticum

Peyronie's disease

PDUFA date

9/6/13

Celgene Corp. (NASDAQ:CELG)

Pomalidomide

Relapsed and/or refractory multiple myeloma (MM)

PDUFA date; MAA action

2/10/13; 2H13

Celgene Corp. (NASDAQ:CELG)/ Otsuka Pharmaceutical Co. Ltd.

Abraxane nab-paclitaxel

Advanced non-small cell lung cancer (NSCLC)

Regulatory action in Japan, Australia and New Zealand

2013

Clinuvel Pharmaceuticals Ltd. (ASX:CUV; Xetra:UR9)

Scenesse afamelanotide

Erythropoietic protoporphyria

MAA action

1H13

Covidien plc (NYSE:COV)/Nuvo Research Inc. (TSX:NRI)

Pennsaid 2% diclofenac

Osteoarthritis (OA) of the knee

PDUFA date

3/4/13

CSL Ltd. (ASX:CSL)

4-factor prothrombin complex concentrate (PCC)

Reversal of vitamin K antagonist therapy in patients with acute major bleeding

PDUFA date

1/28/13

Depomed Inc. (NASDAQ:DEPO)

Serada gabapentin GR

Moderate to severe vasomotor symptoms associated with menopause

FDA panel; PDUFA date

3/4/13; 5/31/13

Dynavax Technologies Corp. (NASDAQ:DVAX)

Heplisav vaccine

Prevent HBV infection

PDUFA date

2/24/13

Eisai Co. Ltd. (Tokyo:4523; Osaka:4523)

Aciphex delayed-release rabeprazole

Gastroesophageal reflux disease (GERD) in children 1-11 years of age

PDUFA date

3/27/13

Genentech Inc./ImmunoGen Inc. (NASDAQ:IMGN)/ Roche (SIX:ROG; OTCQX:RHHBY)

Trastuzumab emtansine (T-DM1)

Third-line treatment for HER2-positive metastatic breast cancer

PDUFA date

2/26/13

Genentech Inc./Novartis AG (NYSE:NVS; SIX:NOVN)/ Roche (SIX:ROG; OTCQX:RHHBY)

Lucentis ranibizumab

Once-monthly 0.5 mg to be dosed as-needed to treat wet age-related macular degeneration (AMD)

PDUFA date

1Q13

H. Lundbeck A/S (CSE:LUN)/ Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

Brintellix vortioxetine

Major depressive disorder (MDD)

PDUFA date

10/2/13

H. Lundbeck A/S (CSE:LUN)/ Otsuka Pharmaceutical Co. Ltd.

Once-monthly depot formulation of aripiprazole

MM

PDUFA date

2/28/13

Hemispherx Biopharma Inc. (NYSE-M:HEB)

Ampligen rintatolimod

Chronic fatigue syndrome (CFS)

PDUFA date

2/2/13

Hyperion Therapeutics Inc. (NASDAQ:HPTX)/ Medicis Pharmaceutical Corp. (NYSE:MRX)

Ravicti glycerol phenylbutyrate

Chronic urea cycle disorders

PDUFA date

1/23/13

Impax Laboratories Inc. (NASDAQ:IPXL)/ GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

Rytary extended-release carbidopa/levodopa

Idiopathic Parkinson's disease

PDUFA date

1/21/13

Isis Pharmaceuticals Inc. (NASDAQ:ISIS)/ Sanofi (Euronext:SAN; NYSE:SNY)

Kynamro mipomersen

hoFH

PDUFA date

1/29/13

Johnson & Johnson (NYSE:JNJ)

Invocana canagliflozin

Type II diabetes

FDA panel; PDUFA date

1/10/13; March

Navidea Biopharmaceuticals Inc. (NYSE-M:NAVB)/ Cardinal Health Inc. (NYSE:CAH)

Lymphoseek tilmanocept

Intraoperative lymphatic imaging

PDUFA date

4/30/13

Noven Pharmaceuticals Inc./ Hisamitsu Pharmaceutical Co. Inc. (Tokyo:4530; Osaka:4530)

Low-dose paroxetine mesylate

Moderate to severe vasomotor symptoms associated with menopause

FDA panel; PDUFA date

3/4/13; 6/28/13

Novartis AG (NYSE:NVS; SIX:NOVN)

Exjade deferasirox

Chronic iron overload in patients with non-transfusion- dependent thalassemia

sNDA approval

1Q13

NuPathe Inc. (NASDAQ:PATH)

Zelrix sumatriptan transdermal patch

Migraine

PDUFA date

1/17/13

Orexo AB (SSE:ORX)

Zubsolv buprenorphine/ naloxone

Opioid dependence

PDUFA date

7/6/13

Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY)

Bronchitol mannitol

Cystic fibrosis (CF)

FDA panel; PDUFA date

1/30/13; 3/18/13

QuatRx Pharmaceuticals Co./ Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507)

Ophena ospemifene

Vulvar and vaginal atrophy due to menopause

PDUFA date

2/26/13

Raptor Pharmaceutical Corp. (NASDAQ:RPTP)

Procysbi cysteamine bitartrate (RP103)

Nephropathic cystinosis

PDUFA date; MAA action

4/30/13; 1H13

Santarus Inc. (NASDAQ:SNTS)/ Cosmo Pharmaceuticals S.p.A. (SIX:COPN)

Uceris budesonide using Cosmo's drug delivery technology

Ulcerative colitis (UC)

PDUFA date

1/16/13

Seattle Genetics Inc. (NASDAQ:SEGN)/ Millennium Pharmaceuticals Inc./ Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

Adcetris brentuximab vedotin

Hodgkin's lymphoma and systemic anaplastic large cell lymphoma

NDS action

Early 2013

Sucampo Pharmaceuticals Inc. (NASDAQ:SCMP)

Amitiza lubiprostone

Opioid-induced constipation

PDUFA date

Late April

Theravance Inc. (NASDAQ:THRX)/ GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

Breo fluticasone furoate/ vilanterol

Chronic obstructive pulmonary disease (COPD)

FDA panel; PDUFA date

3/7/13; 5/12/13

Titan Pharmaceuticals Inc. (OTCBB:TTNP)/ Braeburn Pharmaceuticals S.p.r.l.

Probuphine buprenorphine

Opioid dependence

PDUFA date

April

Zogenix Inc. (NASDAQ:ZGNX)/Alkermes plc (NASDAQ:ALKS)

Zohydro ER hydrocodone bitartrate using Alkermes' drug delivery technology

Moderate to severe chronic pain

PDUFA date

3/1/13