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Aptima CT Assay. 2020-08-17 The FDA granted accelerated approval to Viltepso (viltolarsen) to treat Duchenne muscular dystrophy patients (DMD) who have a confirmed mutation of the DMD gene amenable to exon 53 skipping, pitting it against Sarepta Therapeutics Inc.’s Vyondys (golodirsen), which was given accelerated approval last year in a controversial decision by the FDA following an agency complete response letter 2020-08-13 BANNOCKBURN, Ill., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Option Care Health, Inc. (“ Option Care Health”) (NASDAQ: OPCH), the nation’s largest independent provider of home and alternate site infusion services, has been selected to participate in the limited distribution network of VILTEPSO™ (viltolarsen) for patients with Duchenne Muscular Dystrophy (“DMD”) who are amenable to exon 53 The US Food and Drug Administration granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This is the second FDA-approved targeted treatment for patients with this type of mutation.

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Pharmacology, adverse reactions, warnings and side effects. 2020-08-13 About GoodRx Prices and Viltepso Coupons GoodRx‘s cash prices are based on multiple sources, including published price lists, purchases, claims records, and data provided by pharmacies. Our discount and coupon prices are based on contracts between a pharmacy (or pharmacy purchasing group) and a Pharmacy Benefit Manager (PBM), who provides prices to us. Viltepso (viltolarsen) is a medication used for the treatment of Duchenne muscular dystrophy (DMD) with a confirmed deficiency of the dystrophin gene amenable to exon 53 skipping therapy. Viltepso is approved in Japan under the name Viltolarsen (NS-065/NCNP-01). We have it available to order as well. About VILTEPSO™ (viltolarsen) injection Prior to its approval in the U.S., VILTEPSO was granted Priority Review as well as Rare Pediatric Disease, Orphan Drug and Fast Track Designations.

Comprehensive Cancer Network Drug Points, and package insert) as defined in the Social.

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NDC: • Viltepso 250 mg/5 mL single-dose vial: 73292-0011-xx VII. References 1. Viltepso [package insert]. Paramus, NJ; NS Pharma, Inc.; August 2020. Accessed August 2020.

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In March 2020 , VILTEPSO was approved in Japan for the treatment of patients with DMD who are amenable to exon 53 skipping therapy. VILTEPSO (viltolarsen) injection is a sterile, preservative-free, aqueous solution for intravenous administration.

2020-08-17 The FDA granted accelerated approval to Viltepso (viltolarsen) to treat Duchenne muscular dystrophy patients (DMD) who have a confirmed mutation of the DMD gene amenable to exon 53 skipping, pitting it against Sarepta Therapeutics Inc.’s Vyondys (golodirsen), which was given accelerated approval last year in a controversial decision by the FDA following an agency complete response letter 2020-08-13 BANNOCKBURN, Ill., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Option Care Health, Inc. (“ Option Care Health”) (NASDAQ: OPCH), the nation’s largest independent provider of home and alternate site infusion services, has been selected to participate in the limited distribution network of VILTEPSO™ (viltolarsen) for patients with Duchenne Muscular Dystrophy (“DMD”) who are amenable to exon 53 The US Food and Drug Administration granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This is the second FDA-approved targeted treatment for patients with this type of mutation. Find patient medical information for Viltepso intravenous on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Package Insert For in-vitro diagnostic use Availability of individual reports may be subject to product purchased. Table of contents Genetic Health Risk Intended use Important warnings and limitations Test performance User studies Specific test information BRCA1/BRCA2 (Selected Variants) Indications for use • Package Insert For Information Only - Not A Controlled Copy.
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Aptima CT Assay. 2020-08-17 The FDA granted accelerated approval to Viltepso (viltolarsen) to treat Duchenne muscular dystrophy patients (DMD) who have a confirmed mutation of the DMD gene amenable to exon 53 skipping, pitting it against Sarepta Therapeutics Inc.’s Vyondys (golodirsen), which was given accelerated approval last year in a controversial decision by the FDA following an agency complete response letter 2020-08-13 BANNOCKBURN, Ill., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Option Care Health, Inc. (“ Option Care Health”) (NASDAQ: OPCH), the nation’s largest independent provider of home and alternate site infusion services, has been selected to participate in the limited distribution network of VILTEPSO™ (viltolarsen) for patients with Duchenne Muscular Dystrophy (“DMD”) who are amenable to exon 53 The US Food and Drug Administration granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This is the second FDA-approved targeted treatment for patients with this type of mutation.

VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients amenable to exon 53 skipping. Accelerated approval is based on an increase in dystrophin. There is an ongoing study to confirm the clinical benefit of VILTEPSO. If you are a healthcare provider who treats patients with DMD The use of viltolarsen (Viltepso) for Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping does not meet the definition of medical necessity, defined as delivery of a service by a qualified healthcare provider, exercising prudent clinical Viltepso is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with Viltepso. Viltepso 250 mg/5 mL single-dose vial: 73292-0011-xx VII. References 1.
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VILTEPSO (viltolarsen) injection is a sterile, preservative-free, aqueous solution for intravenous administration. VILTEPSO is a clear and colorless solution. VILTEPSO is supplied in single-dose vials containing 250 mg/5 mL viltolarsen (50 mg/mL) in 0.9% sodium chloride. 2020-08-12 Viltepso [package insert]. Paramus, NJ: NS Pharma; 2020. The Food and Drug Administration (FDA) has granted accelerated approval to Viltepso (viltolarsen; NS Pharma) for the treatment of Duchenne o Viltepso dosing for DMD is in accordance with the United States Food and Drug Administration approved labeling; and o Viltepso is not used concomitantly with other exon skipping therapies for DMD; and o Reauthorization will be for no more than 12 months. Viltepso will not be covered for other forms of muscular dystrophy.

Practice guideline update summary: Corticosteroid treatment of Duchenne muscular dystrophy: Report of the Guideline VILTEPSO™ (viltolarsen) Prior Auth Criteria Proprietary Information. Restricted Access – Do not disseminate or copy without approval. ©2020, Magellan Rx Management • J3490 – Unclassified drugs. NDC: • Viltepso 250 mg/5 mL single-dose vial: 73292-0011-xx VII. References 1. Viltepso [package insert]. Paramus, NJ; NS Pharma, Inc Viltepso (viltolarsen) injection is a sterile, preservative-free, aqueous solution for intravenous administration.
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VILTEPSO™ is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping (FDA label document). 8.2 8.5 11 12.1 12.2 13 13.1 16.1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use About VILTEPSO™ (viltolarsen) injection. Prior to its approval in the U.S., VILTEPSO was granted Priority Review as well as Rare Pediatric Disease, Orphan Drug and Fast Track Designations. In March 2020, VILTEPSO was approved in Japan for the treatment of patients with DMD who are amenable to exon 53 skipping therapy.

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Table of contents Genetic Health Risk Intended use Important warnings and limitations Test performance User studies Specific test information BRCA1/BRCA2 (Selected Variants) Indications for use 2020-08-13 · PARAMUS, N.J., Aug. 12, 2020 /PRNewswire/ — NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President Shigenobu Maekawa), announced today that the U.S. Food & Drug Administration (FDA) has approved VILTEPSO™ (viltolarsen) injection for patients with Duchenne muscular dystrophy (DMD) who are amenable to … The FDA granted accelerated approval to Viltepso (viltolarsen) to treat Duchenne muscular dystrophy patients (DMD) who have a confirmed mutation of the DMD gene amenable to exon 53 skipping, pitting it against Sarepta Therapeutics Inc.’s Vyondys (golodirsen), which was given accelerated approval last year in a controversial decision by the FDA following an agency complete response letter BANNOCKBURN, Ill., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Option Care Health, Inc. (“ Option Care Health”) (NASDAQ: OPCH), the nation’s largest independent provider of home and alternate site infusion services, has been selected to participate in the limited distribution network of VILTEPSO™ (viltolarsen) for patients with Duchenne Muscular Dystrophy (“DMD”) who are amenable to exon 53 • Package Insert For Information Only - Not A Controlled Copy.

2020-08-12 Viltepso [package insert]. Paramus, NJ: NS Pharma; 2020. The Food and Drug Administration (FDA) has granted accelerated approval to Viltepso (viltolarsen; NS Pharma) for the treatment of Duchenne o Viltepso dosing for DMD is in accordance with the United States Food and Drug Administration approved labeling; and o Viltepso is not used concomitantly with other exon skipping therapies for DMD; and o Reauthorization will be for no more than 12 months. Viltepso will not be covered for other forms of muscular dystrophy. Applicable Codes Viltepso FDA Approval History.