2024年5月4日发(作者：)
Products Approved from April to December 2010: New Drugs
Review
Category
3-1
Approval Date
Apr. 16, 2010
Brand Name
(Applicant Company)
Rozerem Tablets 8 mg
(Takeda Pharmaceutical Company Limited)
DuoTrav Combination Ophthalmic Solution
(Alcon Japan Ltd.)
Remicade for I.V. Infusion 100
(Mitsubishi Tanabe Pharma Corporation)
Approval/Active Ingredient(s)
Partial(underlined: new active
Changeingredient)
ApprovalRamelteon
Notes
A drug with a new active ingredient indicated for the
improvement of difficulty with sleep onset in insomnia.
A new combination drug indicated for the treatment of
glaucoma and ocular hypertension.
A drug with a new additional indication and a new
dosage for the treatment of ankylosing spondylitis in
patients who have not responded sufficiently to
conventional treatments.
[Orphan drug]
Drugs with a new active ingredient indicated for the
treatment of unresectable, advanced or recurrent
colorectal cancer with wild-type KRAS.
3-2Apr. 16, 2010ApprovalTravoprost/timolol maleate
6-1Apr. 16, 2010ChangeInfliximab (genetical
recombination)
Oncology
drugs
Apr. 16, 2010Vectibix for Intravenous Infusion 100 mg
(Takeda Pharmaceutical Company Limited)
Vectibix for Intravenous Infusion 100 mg "Takeda Bio"
(Takeda Bio Development Center Limited)
Lyrica Capsules 25 mg
Lyrica Capsules 75 mg
Lyrica Capsules 150 mg
(Pfizer Japan Inc.)
Diquas Ophthalmic Solution 3%
(Santen Pharmaceutical Co., Ltd.)
Fentos Tape 1 mg
Fentos Tape 2 mg
Fentos Tape 4 mg
Fentos Tape 6 mg
Fentos Tape 8 mg
(Hisamitsu Pharmaceutical Co., Inc.)
Cosopt Ophthalmic Solution
(Banyu Pharmaceutical Co., Ltd.)
ApprovalPanitumumab (genetical
recombination）
Approval
3-1Apr. 16, 2010ApprovalPregabalin
Approval
Approval
ApprovalDiquafosoI sodium
Drugs with a new active ingredient indicated for the
treatment of postherpetic neuralgia.
6-1Apr. 16, 2010A drug with a new active ingredient indicated for the
treatment of dry eye.
Drugs with a new route of administration indicated for
analgesia in various types of cancer associated with
moderate to severe pain which cannot be managed by
treatments with non-opioid analgesics or weak opioid
analgesics (for use only in patients who switch from an
opioid analgesic).
3-2Apr. 16, 2010
Approval
Fentanyl citrate
Approval
Approval
Approval
Approval
3-2Apr. 16, 2010ApprovalDorzolamideA new combination drug indicated for the treatment of
hydrochloride/timolol maleateglaucoma and ocular hypertension in patients who
have not responded sufficiently to other glaucoma
drugs.
Approval
Alogliptin benzoate
Approval
Approval
Drugs with a new active ingredient indicated for the
treatment of type 2 diabetes (for use only in patients
with inadequate glycemic control by following
treatments:
1. Treatment by diet and exercise only
2. In addition to treatment by diet and exercise,
treatment by alpha-glucosidase inhibitor).
New combination drugs indicated for the treatment of
type 2 diabetes (for use only in patients appropriate to
the treatment by concomitant therapy of pioglitazone
hydrochloride and metformin hydrochloride).
Drugs with a new route of administration and a new
indication for the treatment of renal anemia.
6-2Apr. 16, 2010Nesina Tablets 6.25 mg
Nesina Tablets 12.5 mg
Nesina Tablets 25 mg
(Takeda Pharmaceutical Company Limited)
6-2Apr. 16, 2010Metact Combination Tablets LD
Metact Combination Tablets HD
(Takeda Pharmaceutical Company Limited)
ApprovalPioglitazone
Approvalhydrochloride/metformin
hydrochloride
1Apr. 16, 2010Nesp Injection 10 µg/1 mL Plastic Syringe
Nesp Injection 15 µg/1 mL Plastic Syringe
Nesp Injection 20 µg/1 mL Plastic Syringe
Nesp Injection 30 µg/1 mL Plastic Syringe
Nesp Injection 40 µg/1 mL Plastic Syringe
Nesp Injection 60 µg/0.6 mL Plastic Syringe
Nesp Injection 120 µg/0.6 mL Plastic Syringe
Nesp Injection 180 µg/0.9 mL Plastic Syringe
(Kyowa Hakko Kirin Co., Ltd.)
Unisia Combination Tablets LD
Unisia Combination Tablets HD
(Takeda Pharmaceutical Company Limited)
Soliris for Intravenous Infusion 300 mg
(Alexion Pharma K.K.)
ApprovalDarbepoetin alfa (genetical
Approvalrecombination)
Approval
Approval
Approval
Approval
Approval
Approval
2Apr. 16, 2010ApprovalCandesartan
Approvalcilexetil/amlodipine besilate
New combination drugs indicated for the treatment of
hypertension.
1Apr. 16, 2010ApprovalEculizumab (genetical
recombination)
A drug with a new active ingredient indicated to
reduce hemolysis in patients with paroxysmal
nocturnal hemoglobinuria.
[Orphan drug]
A drug with a new dosage indicated for the treatment
of hypogammaglobulinemia or agammaglobulinemia.
Blood
products
May 13, 2010Venoglobulin IH 5% I.V. 2.5 g/50 mL
(Benesis Corporation)
ChangePolyethylene glycol treated
human normal
immunoglobulin
Freeze-dried sulfonated
human normal
immunoglobulin
Blood
products
Blood
products
May 13, 2010Kenketsu Venilon-I for Intravenous Injection 2500 mg
(Kaketsuken [The Chemo-Sero-Therapeutic Research
Institute])
Kenketu Glovenin-I for I.V. Injection 2500 mg
(Nihon Pharmaceutical Co., Ltd.)
ChangeA drug with a new dosage indicated for the treatment
of hypogammaglobulinemia or agammaglobulinemia.
May 13, 2010ChangeFreeze-dried polyethyleneA drug with a new dosage indicated for the treatment
glycol treated human normalof hypogammaglobulinemia or agammaglobulinemia.
immunoglobulin
pH4-treated acidic human
normal immunoglobulin
Freeze-dried pH4 treated
human immunoglobulin
Freeze-dried ion-exchange-
resin treated human normal
immunoglobulin
Flecainide acetate
A drug with a new dosage indicated for the treatment
of hypogammaglobulinemia or agammaglobulinemia.
A drug with a new dosage indicated for the treatment
of hypogammaglobulinemia or agammaglobulinemia.
A drug with a new dosage indicated for the treatment
of hypogammaglobulinemia or agammaglobulinemia.
Blood
products
Blood
products
Blood
products
May 13, 2010Nisseki Polyglobin-N 5% I.V. 2.5 g/50 mL
(Japanese Red Cross Society)
Sanglopor I.V. Infusion 2.5 g
(CSL Behring AG; designated marketing authorization holder,
CSL Behring K.K.)
Gammagard for Intravenous Injection 2.5 g
(Baxter Limited)
Change
May 13, 2010Change
May 13, 2010Change
2May 13, 2010Tambocor Tablets 50 mg
Tambocor Tablets 100 mg
(Eisai Co., Ltd.)
Change
Change
Drugs with a new additional indication and a new
dosage for the treatment of tachyarrhythmia
(paroxysmal atrial fibrillation/flutter, paroxysmal
supraventricular tachycardia, ventricular tachycardia)
in children.
[Expedited review]
Products Approved from April to December 2010: New Drugs
Review
Approval Date
Category
1
Brand Name
(Applicant Company)
Approval
/Partial
Change
Change
Active Ingredient(s)
(underlined: new active
ingredient)
Infliximab (genetical
recombination)
Notes
A drug with a new additional indication and a new
dosage for the treatment of moderate to severe
ulcerative colitis (for use only in patients who have
not sufficiently responded to conventional
treatments).
Drugs with a new dosage indicated for the treatment
of type 2 diabetes mellitus (for use only in patients
who have not responded sufficiently to diet and
exercise therapies alone).
A drug with a new additional indication and a new
dosage for the treatment of non-erosive reflux
disease.
A drug with a new dosage in a new additional
dosage form indicated for autologous blood storage.
A drug with a new active ingredient indicated for the
treatment of relapsed or refractory multiple
myeloma.
[Orphan drug]
A drug with a new additional indication and a new
dosage for the treatment of multiple myeloma.
[Expedited review]
Drugs with a new additional indication for
helicobacter pylori (H. pylori) eradication therapy for
gastric MALT lymphoma, for the stomach after
endoscopic treatment of early gastric cancer, and
for idiopathic thrombocytopenic purpura, in H. pylori
infection.
Jun. 18, 2010Remicade for I.V. Infusion 100
(Mitsubishi Tanabe Pharma Corporation)
6-2Jun. 18, 2010Amaryl 0.5 mg Tablets
Amaryl 1 mg Tablets
Amaryl 3 mg Tablets
(Sanofi-Aventis K.K.)
Jun. 18, 2010Pariet Tablets 10 mg
(Eisai Co., Ltd.)
Jun. 18, 2010Epogin Subcutaneous Injection Syringe 24000
(Chugai Pharmaceutical Co., Ltd.)
Change
Change
Change
Change
Glimepiride
1Sodium rabeprazole
Blood
products
ApprovalEpoetin beta (genetical
recombination)
ApprovalLenalidomide hydrateOncologyJun. 25, 2010Revlimid Capsules 5 mg
drugs(Celgene K.K.)
OncologyJun. 18, 2010LenaDex Tablets 4 mg
drugs(Celgene K.K.)
ApprovalDexamethasone
4Jun. 18, 2010(1) Takepron Capsules 15
Takepron Capsules 30
(2) Takepron OD Tablets 15
Takepron OD Tablets 30
(Takeda Pharmaceutical Company Limited)
(3) Omepral Tablets 10
Omepral Tablets 20
(AstraZeneca K.K.)
(4) Omeprazon Tablets 10 mg
Omeprazon Tablets 20 mg
(Mitsubishi Tanabe Pharma Corporation)
(5) Pariet Tablets 10 mg
(Eisai Co., Ltd.)
(6) Pasetocin Capsule 125
Pasetocin Capsule 250
(7) Pasetocin Tablets 250
(Kyowa Hakko Kirin Co., Ltd.)
(8) Sawacillin Capsules 250
(9) Sawacillin Tablets 250
(Astellas Pharma Inc.)
(10) Amolin Capsules 125
Amolin Capsules 250
(11) 10％ Amolin Fine Granules
(Takeda Pharmaceutical Company Limited)
(12) Clarith Tab. 200
(Taisho Pharmaceutical Co., Ltd.)
(13) Klaricid Tablets 200 mg
(Abbott Japan Co., Ltd.)
(14) Flagyl Oral Tablet 250 mg
(Shionogi & Co., Ltd.)
(15) Lansap 400
Lansap 800
(Takeda Pharmaceutical Company Limited)
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
Change
(1)(2)
Lansoprazole
(3)(4)
Omeprazole
(5)
Sodium rabeprazole
(6)(7)(8)(9)(10)(11)
Amoxicillin hydrate
(12)(13)
Clarithromycin
(14)
Metronidazole
(15)
Lansoprazole/amoxicillin
hydrate/clarithromycin
发布评论