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通過美國食品藥品管理局新藥審批的藥物(2020年2月)

MIMS醫藥資訊2020-04-09 09:06:13人已圍觀

2020年2月首次通過美國食品藥品管理局新藥審批的藥物,包括新化學成份和新生物制劑。但未包括暫時審批的藥物。藥物通過新藥審批后可能還需要補充申請批準。

ANJESO

  • Active Ingredient(s): Meloxicam

  • Strength: 30 mg/mL

  • Dosage Form(s) / Route(s): Injectable; injection

  • Company: Baudax Bio, Inc.

  • Approval Date: 20 February 2020

  • Submission Classification: Type 3 - New Dosage Form

  • Indication(s): Indicated for use in adults for management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.


NEXLETOL

  • Active Ingredient(s): Bempedoic acid

  • Strength: 180 mg

  • Dosage Form(s) / Route(s): Tablet; oral

  • Company: Esperion Therapeutics, Inc.

  • Approval Date: 21 February 2020

  • Submission Classification: Type 1 - New Molecular Entity

  • Indication(s): Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.


VYEPTI

  • Active Ingredient(s): Eptinezumab-jjmr

  • Strength: 100 mg/mL

  • Dosage Form(s) / Route(s): Injectable; injection

  • Company: Lundbeck Seattle BioPharmaceuticals, Inc.

  • Approval Date: 21 February 2020

  • Submission Classification: Not available

  • Indication(s): Indicated for the preventive treatment of migraine in adults.


BARHEMSYS

  • Active Ingredient(s): Amisulpride

  • Strength: 5 mg/2 mL (2.5 mg/mL)

  • Dosage Form(s) / Route(s): Injectable; injection

  • Company: Acacia Pharma, Ltd.

  • Approval Date: 26 February 2020

  • Submission Classification: Type 1 - New Molecular Entity

  • Indication(s): Indicated in adults for:

    • Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.

    • Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class of have not received prophylaxis.


NEXLIZET

  • Active Ingredient(s): Bempedoic acid; ezetimibe

  • Strength: 180 mg/10 mg

  • Dosage Form(s) / Route(s): Tablet; oral

  • Company: Esperion Therapeutics, Inc.

  • Approval Date: 26 February 2020

  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination

  • Indication(s): Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular diseae who require additional lowering of LDL-C.


NURTEC ODT

  • Active Ingredient(s): Rimegepant

  • Strength: 75 mg

  • Dosage Form(s) / Route(s): Tablet, orally disintegrating; oral

  • Company: Biohaven Pharma Holding Co., Ltd.

  • Approval Date: 27 February 2020 

  • Submission Classification: Type 1 - New Molecular Entity

  • Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.


PIZENSY

  • Active Ingredient(s): Lactitol monohydrate (BLI400)

  • Strength: 10 g; 20 g

  • Dosage Form(s) / Route(s): Solution; oral

  • Company: Braintree Labs

  • Approval Date: 12 February 2020

  • Submission Classification: Type 1 - New Molecular Entity

  • Indication(s): Indicated for the treatment of chronic idiopathic constipation (CIC) in adults.


PEMFEXY

  • Active Ingredient(s): Pemetrexed

  • Strength: 25 mg/mL

  • Dosage Form(s) / Route(s): Injectable; injection

  • Company: Eagle Pharms

  • Approval Date: 08 February 2020

  • Submission Classification: Type 5 - New Formulation or New Manufacturer

  • Indication(s): Indicated for:

    • in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC).

    • as a single agent for the maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progresses after four cycles of platinum-based first-line chemotherapy.

    • as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy.

    • in combination with cisplatin for the initial treatment, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.


TWIRLA

  • Active Ingredient(s): Levonorgestrel; ethinyl estradiol

  • Strength: 120 mcg; 30 mcg

  • Dosage Form(s) / Route(s): System; transdermal

  • Company: Agile Therapeutics, Inc.

  • Approval Date: 14 February 2020

  • Submission Classification: Type 3 - New Dosage Form

  • Indication(s): Indicated as a method of contraception for use in women of reproductive potential with a BMI <30 kg/m2 for whom a combined hormonal contraceptive is appropriate.


PROCYSBI

  • Active Ingredient(s): Cysteamine bitartrate

  • Strength: 75 mg; 300 mg

  • Dosage Form(s) / Route(s): Granule, delayed release; oral

  • Company: Horizon Pharma USA

  • Approval Date: 14 February 2020

  • Submission Classification: Not available

  • Indication(s): Indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.


更多相關資訊:

通過美國食品藥品管理局新藥審批的藥物(2020年1月)

通過美國食品藥品管理局新藥審批的藥物(2019年12月)

通過美國食品藥品管理局新藥審批的藥物(2019年11月)


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