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New Drug Approvals Archive - February 2020

See also: New Indications and Dosage Forms for February 2020

February 2020

Pemfexy (pemetrexed) Injection

Date of Approval: February 8, 2020
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma

Pemfexy (pemetrexed for injection) is a branded alternative to Alimta for the treatment of nonsquamous non-small cell lung cancer and malignant pleural mesothelioma.

Pizensy (lactitol) Powder for Oral Solution

Date of Approval: February 12, 2020
Company: Braintree Laboratories, Inc.
Treatment for: Chronic Idiopathic Constipation

Pizensy (lactitol) is an osmotic laxative indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Twirla (ethinyl estradiol and levonorgestrel) Transdermal System

Date of Approval: February 14, 2020
Company: Agile Therapeutics, Inc.
Treatment for: Contraception

Twirla (ethinyl estradiol and levonorgestrel transdermal system) is a low-dose combined hormonal contraceptive patch for birth control.

Anjeso (meloxicam) Injection

Date of Approval: February 20, 2020
Company: Baudax Bio, Inc.
Treatment for: Pain

Anjeso (meloxicam) is a non-steroidal anti-inflammatory drug (NSAID) injection indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

Nexletol (bempedoic acid) Tablets

Date of Approval: February 21, 2020
Company: Esperion Therapeutics, Inc.
Treatment for: Heterozygous Familial Hypercholesterolemia

Nexletol (bempedoic acid) is a first-in-class, adenosine triphosphate-citrate lyase (ACL) inhibitor for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-Cholesterol.

Vyepti (eptinezumab-jjmr) Injection

Date of Approval: February 21, 2020
Company: Lundbeck
Treatment for: Migraine Prophylaxis

Vyepti (eptinezumab-jjmr) is a calcitonin gene-related peptide antagonist indicated for the prevention of migraine in adults.

Nexlizet (bempedoic acid and ezetimibe) Tablets

Date of Approval: February 26, 2020
Company: Esperion Therapeutics
Treatment for: Heterozygous Familial Hypercholesterolemia

Nexlizet (bempedoic acid and ezetimibe) is an adenosine triphosphate-citrate lyase (ACL) inhibitor and a cholesterol absorption inhibitor combination 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.

Barhemsys (amisulpride) Injection

Date of Approval: February 26, 2020
Company: Acacia Pharma
Treatment for: Nausea/Vomiting -- Postoperative

Barhemsys (amisulpride) is a dopamine-2 (D2) antagonist for the management of post-operative nausea and vomiting (PONV).

Nurtec ODT (rimegepant) Orally Disintegrating Tablets (ODT)

Date of Approval: February 27, 2020
Company: Biohaven Pharmaceutical Holding Company Ltd.
Treatment for: Migraine

Nurtec ODT (rimegepant) is an orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist for the acute treatment of migraine.

Advil Dual Action (ibuprofen and acetaminophen) Tablets

Date of Approval: February 28, 2020
Company: GSK Consumer Healthcare
Treatment for: Pain

Advil Dual Action (ibuprofen with acetaminophen) is an over-the-counter (OTC) fixed-dose combination of ibuprofen (the nonsteroidal anti-inflammatory drug (NSAID) contained in Advil) and acetaminophen (the active ingredient in Tylenol) for the relief of pain.

Pizensy (lactitol) Powder for Oral Solution

Date of Approval: February 12, 2020
Company: Braintree Laboratories, Inc.
Treatment for: Chronic Idiopathic Constipation

Pizensy (lactitol) is an osmotic laxative indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

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