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Full approvals of NDAs and BLAs
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New Drug
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Argatroban
Eagle
5S
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Direct thrombin inhibitor approved under the 505(b)(2) NDA pathway for treatment of thrombosis
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6/29/2011
(22-434)
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Ceftazidime for Injection and Dextrose Injection
B Braun
5S
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New packaging in a Duplex Container approved under the 505(b)(2) NDA pathway for the third-generation cephalosporin antibiotic
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6/13/2011
(50-823)
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Codeine
Roxane
5S
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Oral solution of the opioid analgesic approved under the 505(b)(2) NDA pathway for management of mild to moderately severe pain when use of an opioid analgesic is appropriate
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6/30/2011
(202-245)
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Docetaxel
Accord
5S
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Microtubule inhibitor approved via the 505(b)(2) NDA pathway for use as a single agent for locally advanced or metastatic breast cancer after chemotherapy failure and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive breast cancer; as a single agent for locally advanced or metastatic non-small cell lung cancer after platinum therapy failure and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC; with prednisone in androgen independent (hormone refractory) metastatic prostate cancer; with cisplatin and fluorouracil for untreated, advanced gastric adenocarcinoma, including the gastroesophageal junction; and with cisplatin and fluorouracil for induction treatment of locally advanced squamous cell carcinoma of the head and neck
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6/8/2011
(201-195)
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Docetaxel
Sandoz
5S
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Microtubule inhibitor approved via the 505(b)(2) NDA pathway for use in locally advanced or metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and hormone refractory metastatic prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of the head and neck
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6/29/2011
(201-525)
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Lazanda
Fentanyl
Archimedes
3S
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Nasal spray formulation of the opioid analgesic approved via the 505(b)(2) NDA pathway for management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to regular opioid therapy for their underlying persistent cancer pain
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6/30/2011
(22-569)
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Levothyroxine
APP
7S
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L-thyroxine synthetic thyroid hormone product in I.V. form approved via the 505(b)(2) NDA pathway for treatment of myxedema coma, a life-threatening complication of hypothyroidism
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6/24/2011
(202-231)
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Morphine
Lannett
3S
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Oral solution of the opioid analgesic approved via the 505(b)(2) NDA pathway for management of moderate to severe acute and chronic pain in opioid-tolerant patients
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6/23/2011
(201-517)
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Oxecta
Oxycodone
King
5P
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Opioid analgesic approved via the 505(b)(2) NDA pathway for management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate
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6/17/2011
(202-080)
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Potiga
Ezogabine
Valeant
1S
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Potassium channel opener for use as adjunctive treatment for adult patients with partial-onset seizures with or without secondary generalization
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6/10/2011
(22-345)
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Rectiv
Nitroglycerin
ProStrakan
3S
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Ointment formulation of the nitrate vasodilator approved via the 505(b)(2) NDA pathway for treatment of moderate to severe pain associated with chronic anal fissure
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6/21/2011
(21-359)
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Rezira
Hydrocodone/ pseudoephedrine
Cypress
4S
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Oral solution antitussive/nasal decongestant combination approved via the 505(b)(2) NDA pathway for relief of cough and nasal congestion associated with the common cold
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6/8/2011
(22-442)
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Suprenza
Phentermine
Citius
3S
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Sympathomimetic amine anorectic in orally dissolving tablets approved via the 505(b)(2) pathway as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (e.g. controlled hypertension, diabetes, hyperlipidemia)
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6/13/2011
(202-088)
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Zutripro
Hydrocodone/ chlorpheniramine/ pseudoephedrine
Cypress
4S
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Antitussive/antihistamine/nasal decongestant combination in oral solution approved via the 505(b)(2) NDA pathway for relief of cough and nasal congestion associated with the common cold and for relief of symptoms including nasal congestion associated with upper respiratory allergies
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6/8/2011
(22-439)
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New Biologic
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Nulojix
Belatacept
Bristol-Myers Squibb
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Selective T-cell costimulation blocker for prophylaxis of organ rejection in adult patients receiving a kidney transplants
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6/15/2011
(125288)
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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
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