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New Drug Approvals 201 New Drug Approvals 201 New Drug Approvals Upneeq (oxymetazoline hydrochloride) treatment of rheumatoid arthritis (RA), juvenile Ophthalmic Solution idiopathic arthritis (JIA), psoriatic arthritis (PsA), Company: Osmotica Pharmaceuticals plc ankylosing spondylitis (AS), Crohn’s disease (CD), Date of Approval: July 8, 2020 ulcerative colitis (UC), and plaque psoriasis (Ps). Treatment for: Blepharoptosis Byfavo (remimazolam) Injection Upneeq (oxymetazoline hydrochloride ophthalmic Company: Cosmo Pharmaceuticals NV solution, 0.1%) is a novel, once-daily ophthalmic Date of Approval: July 2, 2020 formulation of the direct-acting α-adrenergic receptor Treatment for: Sedation agonist oxymetazoline, indicated for the treatment of Byfavo (remimazolam) is an ultra-short-acting, acquired blepharoptosis (droopy eyelid). intravenous benzodiazepine sedative/anesthetic for Inqovi (decitabine and cedazuridine) Tablets the induction and maintenance of procedural sedation Company: Astex Pharmaceuticals, Taiho Oncology, in adults. and Otsuka Pharmaceutical Rukobia (fostemsavir) Extended-Release Tablets Date of Approval: July 7, 2020 Company: ViiV Healthcare Treatment for: Myelodysplastic Syndrome Date of Approval: July 2, 2020 Inqovi (decitabine and cedazuridine) is a nucleoside Treatment for: HIV Infection metabolic inhibitor and cytidine deaminase inhibitor Rukobia (fostemsavir) is a first-in-class, human combination indicated for the treatment of adults with immunodeficiency virus type 1 (HIV-1) gp120- intermediate and high-risk myelodysplastic directed attachment inhibitor indicated for use in syndromes (MDS) including chronic combination with other antiretroviral(s) for the myelomonocytic leukemia (CMML). treatment of HIV-1 infection in heavily treatment- Qwo (collagenase clostridium histolyticum-aaes) experienced adults with multidrug-resistant HIV-1 for Injection infection. Company: Endo International plc Dojolvi (triheptanoin) Oral Liquid Date of Approval: July 6, 2020 Treatment for: Cellulite Company: Ultragenyx Pharmaceutical Inc. Date of Approval: June 30, 2020 Qwo (collagenase clostridium histolyticum-aaes) is a Treatment for: Long-Chain Fatty Acid Oxidation combination of bacterial collagenases indicated for Disorders the treatment of moderate to severe cellulite in the Dojolvi (triheptanoin) is a medium-chain triglyceride buttocks of adult women. indicated as a source of calories and fatty acids for Hulio (adalimumab-fkjp) Injection the treatment of pediatric and adult patients with Company: Mylan Pharmaceuticals Inc. molecularly confirmed long-chain fatty acid Date of Approval: July 6, 2020 oxidation disorders (LC-FAOD). Treatment for: Rheumatoid Arthritis, Juvenile Phesgo (pertuzumab, trastuzumab, and Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing hyaluronidase-zzxf) Injection Spondylitis, Crohn's Disease -- Maintenance, Company: Genentech, Inc. Ulcerative Colitis, Plaque Psoriasis Hulio Date of Approval: June 29, 2020 (adalimumab-fkjp) is a tumor necrosis factor (TNF) Treatment for: Breast Cancer blocker biosimilar to Humira indicated for the 202 New Drug Approvals Phesgo (pertuzumab, trastuzumab, and adult patients with metastatic small cell lung cancer hyaluronidase-zzxf) is a combination of two (SCLC) with disease progression on or after HER2/neu receptor antagonists and the platinum-based chemotherapy. endoglycosidase hyaluronidase indicated for the Lyumjev (insulin lispro-aabc) Injection treatment of early and metastatic HER2-positive Company: Eli Lilly and Company breast cancer, as detected by an FDA-approved Date of Approval: June 15, 2020 companion diagnostic test. Treatment for: Diabetes Type 1, Diabetes Type 2 Mycapssa (octreotide) Delayed-Release Capsules Lyumjev (insulin lispro-aabc) is a rapid-acting Company: Chiasma, Inc. human insulin analog indicated to improve glycemic Date of Approval: June 26, 2020 control in adults with diabetes mellitus. Treatment for: Acromegaly Semglee (insulin glargine) Injection Mycapssa (octreotide) is an oral formulation of the Company: Mylan N.V. and Biocon Ltd. approved somatostatin analog octreotide for the Date of Approval: June 11, 2020 treatment of acromegaly. Treatment for: Diabetes Type 1, Diabetes Type 2 Fintepla (fenfluramine) Oral Solution Semglee (insulin glargine) is a long-acting human Company: Zogenix, Inc. insulin analog indicated to improve glycemic control Date of Approval: June 25, 2020 in adults and pediatric patients with type 1 diabetes Treatment for: Dravet Syndrome mellitus and in adults with type 2 diabetes mellitus. Fintepla (fenfluramine) is an amphetamine derivative Semglee (insulin glargine) Injection indicated for the treatment of seizures associated with Company: Mylan N.V. and Biocon Ltd. Dravet syndrome in patients 2 years of age and older. Date of Approval: June 11, 2020 Gimoti (metoclopramide) Nasal Spray Treatment for: Diabetes Type 1, Diabetes Type 2 Company: Evoke Pharma, Inc. Semglee (insulin glargine) is a long-acting human Date of Approval: June 19, 2020 insulin analog indicated to improve glycemic control Treatment for: Gastroparesis in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Gimoti (metoclopramide) is an intranasal formulation of the approved drug metoclopramide for the relief of Nyvepria (pegfilgrastim-apgf) Injection symptoms of acute and recurrent diabetic Company: Pfizer Inc. gastroparesis in adults. Date of Approval: June 10, 2020 Treatment for: Neutropenia Associated with Zepzelca (lurbinectedin) Injection Chemotherapy Company: PharmaMar and Jazz Pharmaceuticals plc Date of Approval: June 15, 2020 Nyvepria (pegfilgrastim-apgf) is a PEGylated growth Treatment for: Small Cell Lung Cancer colony-stimulating factor biosimilar to Neulasta (pegfilgrastim) used to reduce the incidence of febrile Zepzelca (lurbinectedin) is a selective oncogenic neutropenia in patients treated with chemotherapy. transcription inhibitor indicated for the treatment of Information collected and compiled by: References: www.drugs.com/newdrugs Md. Akbar Hossain Department of Pharmacy ASA University of Science and Technology Bangladesh .
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