September Approvals
|
|
New
Drug
|
|
Product
|
Sponsor
|
Indication
|
Date
Approved
(Application No.)
|
|
Abilify
Aripiprazole, inj.
(3S)
|
Bristol-Myers Squibb
|
Injection
formulation of the antipsychotic for use in the
treatment of agitation associated with schizophrenia
or bipolar I disorder (manic or mixed)
|
9/20/2006
(21-866)
|
|
Duodote
Atropine/pralidoxime, inj.
(5P)
|
Meridian
|
Injectable
combo product for treatment of poisoning by
organophosphorous nerve agents as well as
organophosphorous insecticides
|
9/28/2006
(21-983)
|
|
Duraprep
Iodine/isopropyl alcohol, solution
(4S)
|
3M
|
Solution
for preoperative skin preparation
|
9/29/2006
(21-586)
|
|
Epirubicin,
inj.
(5S)
|
Mayne
|
Lyophilized
injection of the anthracycline for use as a component
of adjuvant therapy in patients with evidence of
axillary node tumor involvement following resection
of primary breast cancer
|
9/15/2006
(50-807)
|
|
Fentora
Fentanyl, tab.
(3S)
|
Cephalon
|
Buccal
tablet formulation of the opioid for management of
breakthrough pain in patients with cancer who are
already receiving and who are tolerant to opioid
therapy for their underlying persistent cancer
pain
|
9/25/2006
(21-947)
|
|
Noxafil
Posaconazole, oral suspension
(1P)
|
Schering-Plough
|
Triazole
antifungal for prophylaxis of invasive
Aspergillus and Candida infections in
patients 13 years of age and older at high risk of
developing these infections due to being severely
immunocompromised
|
9/15/2006
(22-003)
|
|
Pylera
Biskalcitrate potassium/
metronidazole/tetracycline
(1,4S)
|
Axcan
|
Oral
combination agent for eradication of Helicobacter
pylori
|
9/28/2006
(50-786)
|
|
Travatan Z
Travoprost ophthalmic solution, 0.004%
(3S)
|
Alcon
|
Benzalkonium chloride-free formulation of
firm's Travatan for reduction of elevated intraocular
pressure in patients with open-angle glaucoma or
ocular hypertension who are intolerant of other
intraocular pressure-lowering medications or
insufficiently responsive (failed to achieve target
IOP determined after multiple measurements over time)
to other intraocular pressure-lowering
medications
|
9/21/2006
(21-994)
|
|
Verdeso
Desonide foam, 0.05%
(3S)
|
Connetics
|
Low-potency
topical steroid for treatment of mild-to-moderate
atopic dermatitis
|
9/19/2006
(21-978)
|
|
Zolpidem
tartrate
(3S)
|
Biovail
|
Orally
disintegrating tablet formulation of the
imidazopyridine short-term treatment of
insomnia
|
9/21/2006
(21-412)
|
|
P: Priority Review
(drug represents therapeutic gain over existing
therapies) S: Standard review V: Orphan Drug 1: New
molecular entity 2: New Salt 3: New formulation 4:
New combination 5: Already marketed in U.S. by
another firm 6: Already marketed by same firm,
usually a new indication 7: First NDA for already
marketed drug
|
