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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

BARHEMSYS

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

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.

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