Treatment Watch

2591 eventsUpdated today

FDA drug approvals, PDUFA decisions, orphan designations, and breakthrough therapy designations for rare diseases — sourced daily from FDA.gov.

ℹ
FDA data is sourced from FDA.gov and openFDA.
Report missing data
All eventsFDA approval (873)PDUFA date (0)Orphan designation (0)Breakthrough therapy (0)Complete response letter (0)Upcoming only·Year:All2015201420132012201120102009200820072006

51 events · 2010

Dec 15
2010
label expansion
VFEND (VORICONAZOLE)FDA label ↗
· Roerig· NDA021267
Dec 1
2010
label expansion
ZYPREXA RELPREVV (OLANZAPINE PAMOATE)FDA label ↗
· H2-Pharma LLC· NDA022173
Dec 1
2010
label expansion
ZYPREXA INTRAMUSCULAR (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021253
Dec 1
2010
label expansion
ZYPREXA ZYDIS (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021086
Nov 23
2010
label expansion
CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)FDA label ↗
Isolated hyperchlorhidrosis· Janssen Pharmaceuticals, Inc.· NDA021121
Nov 21
2010
label expansion
VFEND (VORICONAZOLE)FDA label ↗
· Roerig· NDA021267
Nov 19
2010
FDA approval
MEFENAMIC ACID (MEFENAMIC ACID)
· Micro Labs Limited· ANDA090562
Nov 18
2010
label expansion
REGLAN (METOCLOPRAMIDE HYDROCHLORIDE)FDA label ↗
· ANI Pharmaceuticals, Inc.· NDA017854
Oct 25
2010
label expansion
LEVETIRACETAM SOLUTION (LEVETIRACETAM)
· Chartwell RX, LLC· ANDA090263
Oct 22
2010
label expansion
AMNESTEEM (ISOTRETINOIN)
· Mylan Pharmaceuticals Inc.· ANDA075945
Oct 22
2010
label expansion
CLARAVIS (ISOTRETINOIN)
· Teva Pharmaceuticals USA, Inc.· ANDA076356
Oct 20
2010
label expansion
USTEKINUMAB (USTEKINUMAB)FDA label ↗
· Janssen Biotech, Inc.· BLA125261
Oct 20
2010
FDA approvalOrphan drug
Herceptin (trastuzumab)

Treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease

Adenocarcinoma of the oesophagus and oesophagogastric junction· Genentech, Inc.
Oct 15
2010
FDA approvalOrphan drug
H.P. Acthar Gel (repository corticotropin or adrenocorticotropic hormone)

To treat infantile spasms

Cryptogenic late-onset epileptic spasms· Questcor Pharmaceuticals, Inc.
Oct 8
2010
FDA approval
ATELVIA (RISEDRONATE SODIUM)FDA label ↗
· Allergan, Inc.· NDA022560
Sep 30
2010
label expansion
ARCALYST (RILONACEPT)
NLRP3-associated autoinflammatory disease· Kiniksa Pharmaceuticals (UK), Ltd.· BLA125249
Sep 24
2010
FDA approvalOrphan drug
Ozurdex (dexamethasone intravitreal implant)

For treatment of non-infectious uveitis affecting the posterior segment of the eye

Granulomatous arthritis of childhood· Allergan
Sep 24
2010
label expansion
OZURDEX (DEXAMETHASONE)FDA label ↗
Multiple myeloma· Allergan, Inc.· NDA022315
Sep 23
2010
label expansion
KESIMPTA (OFATUMUMAB)FDA label ↗
T-cell prolymphocytic leukemia· Novartis Pharmaceuticals Corporation· BLA125326
Aug 31
2010
label expansion
OZURDEX (DEXAMETHASONE)FDA label ↗
Multiple myeloma· Allergan, Inc.· NDA022315
Aug 24
2010
label expansion
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
· Aurobindo Pharma Limited· ANDA090124
Jul 28
2010
FDA approvalOrphan drug
Cuvposa (glycopyrrolate)

To reduce chronic drooling in patients aged 3 - 16 with neurologic conditions associated with problem drooling (e.g. cerebral palsy)

Neurometabolic disorder due to serine deficiency· Shionogi, Inc.
Jul 28
2010
label expansion
LAMOTRIGINE KIT (LAMOTRIGINE)
Lennox-Gastaut syndrome· OWP Pharmaceuticals, Inc.· ANDA078947
Jul 28
2010
label expansion
LAMOTRIGINE (LAMOTRIGINE)
Lennox-Gastaut syndrome· Aurobindo Pharma Limited· ANDA078956
Jul 8
2010
label expansion
ZYPREXA RELPREVV (OLANZAPINE PAMOATE)FDA label ↗
· H2-Pharma LLC· NDA022173
Jun 17
2010
label expansion
VFEND (VORICONAZOLE)FDA label ↗
· Roerig· NDA021267
Jun 2
2010
FDA approval
ADAPALENE (ADAPALENE)FDA label ↗
· Walgreens· ANDA090962
May 27
2010
label expansion
ZYPREXA RELPREVV (OLANZAPINE PAMOATE)FDA label ↗
· H2-Pharma LLC· NDA022173
May 27
2010
label expansion
ZYPREXA INTRAMUSCULAR (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021253
May 27
2010
label expansion
ZYPREXA ZYDIS (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021086
May 14
2010
label expansion
LAMOTRIGINE (LAMOTRIGINE)
Lennox-Gastaut syndrome· Sun Pharmaceutical Industries, Inc.· ANDA078525
May 13
2010
label expansion
GABAPENTIN (GABAPENTIN)
Post-herpetic neuralgia· Actavis Pharma, Inc.· ANDA075350
Apr 30
2010
label expansion
SANDIMMUNE (CYCLOSPORINE)FDA label ↗
Vernal keratoconjunctivitis· Novartis Pharmaceuticals Corporation· NDA050625
Apr 27
2010
label expansion
ZYPREXA RELPREVV (OLANZAPINE PAMOATE)FDA label ↗
· H2-Pharma LLC· NDA022173
Apr 15
2010
label expansion
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE)
· Hospira, Inc.· ANDA089651
Apr 9
2010
label expansion
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE)
· Hospira, Inc.· ANDA088571
Mar 25
2010
label expansion
AMNESTEEM (ISOTRETINOIN)FDA label ↗
· Mylan Pharmaceuticals Inc.· ANDA075945
Mar 25
2010
label expansion
CLARAVIS (ISOTRETINOIN)
· Teva Pharmaceuticals USA, Inc.· ANDA076356
Mar 24
2010
FDA approvalOrphan drug
Xifaxan (rifaximin)

Reduction in the risk of overt hepatic encephalopathy (HE) recurrence in patients greater than or equal to 18 years of age

ARX-related epileptic encephalopathy· Salix Pharmaceuticals, Inc.
Mar 24
2010
FDA approvalOrphan drug
Viread (tenofovir)

Treatment of HIV infection in combination with other antiretroviral agents in patients 12 to less than 18 years of age

Congenital Epstein-Barr virus infection· Gilead Sciences, Inc.
Feb 23
2010
label expansion
LAMOTRIGINE (LAMOTRIGINE)
Lennox-Gastaut syndrome· Aurobindo Pharma Limited· ANDA078956
Feb 22
2010
FDA approvalOrphan drug
Cayston (aztreonam)

To improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa

Congenital insensitivity to pain-hyperhidrosis-absence of cutaneous sensory innervation· Gilead Sciences, Inc.
Feb 19
2010
label expansion
LEVETIRACETAM SOLUTION (LEVETIRACETAM)
· Chartwell RX, LLC· ANDA090263
Feb 17
2010
FDA approval
VALPROATE SODIUM (VALPROATE SODIUM)
· Hikma Pharmaceuticals USA Inc.· ANDA078523
Jan 27
2010
label expansion
ZYPREXA INTRAMUSCULAR (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021253
Jan 27
2010
label expansion
ZYPREXA ZYDIS (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021086
Jan 22
2010
FDA approvalOrphan drug
Ampyra (dalfampridine)

Treatment to improve walking in patients with multiple sclerosis

Multiple sclerosis· Acorda Therapeutics
Jan 21
2010
label expansion
LAMOTRIGINE KIT (LAMOTRIGINE)
Lennox-Gastaut syndrome· OWP Pharmaceuticals, Inc.· ANDA078947
Jan 13
2010
label expansion
CARDENE IV (NICARDIPINE HYDROCHLORIDE)FDA label ↗
· Baxter Healthcare Corporation· NDA019734
Jan 12
2010
label expansion
VALPROIC ACID (VALPROIC ACID)
Juvenile absence epilepsy· Bionpharma Inc.· ANDA073484
Jan 6
2010
label expansion
VALPROIC ACID (VALPROIC ACID)
Juvenile absence epilepsy· Xttrium Laboratories Inc.· ANDA070868

Not medical advice — always consult your healthcare provider before making treatment decisions.

Data sourced from FDA.gov and openFDA, updated daily. Dates are subject to change. Always verify with FDA.gov for official decisions.