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

12 events · FDA approval · 2010

Nov 19
2010
FDA approval
MEFENAMIC ACID (MEFENAMIC ACID)
· Micro Labs Limited· ANDA090562
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 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
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.
Jun 2
2010
FDA approval
ADAPALENE (ADAPALENE)FDA label ↗
· Walgreens· ANDA090962
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.
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.
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 17
2010
FDA approval
VALPROATE SODIUM (VALPROATE SODIUM)
· Hikma Pharmaceuticals USA Inc.· ANDA078523
Jan 22
2010
FDA approvalOrphan drug
Ampyra (dalfampridine)

Treatment to improve walking in patients with multiple sclerosis

Multiple sclerosis· Acorda Therapeutics

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.