Phase 1 Launch Date

Posted By admin On 29/12/21
  • New Drugs

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic approvals, Approval process, New indications & dosage forms

Current status Phase 1, Priority Groups 1-4 Phase 1 (December 2020 - February 2021) Click here for an overview of Phase 1. In Sacramento County, public health representatives say they expect Phase 1B, which includes law enforcement, teachers and people over the age of 75, to begin in February. From Monday (1 June) Household Waste Recycling Centres to begin to reopen. Sites must operate safely, ensuring physical distancing is maintained, and should only be visited when absolutely necessary to minimise journeys. Phase 1 guidance. Route map publication.

Cabenuva (cabotegravir and rilpivirine) Extended-Release Injectable Suspension ( Co-Packaged)

Company:ViiV Healthcare
Date of Approval: January 21, 2021
Treatment for: HIV Infection

Cabenuva (cabotegravir and rilpivirine) is a long-acting, injectable regimen of the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir, and the HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine indicated as a complete regimen for the treatment of HIV-1 infection in adults.

  • FDA Approves Cabenuva (cabotegravir and rilpivirine) Long-Acting Injectable HIV Treatment and Vocabria (cabotegravir) Oral HIV Treatment - January 21, 2021

Verquvo (vericiguat) Tablets

Company:Merck
Date of Approval: January 19, 2021
Treatment for: Heart Failure with Reduced Ejection Fraction (HFrEF)

Verquvo (vericiguat) is a soluble guanylate cyclase (sGC) stimulator indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

  • FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction - January 20, 2021

Gemtesa (vibegron) Tablets

Company: Urovant Sciences
Date of Approval: December 23, 2020
Treatment for: Overactive Bladder Syndrome

Gemtesa (vibegron) is a once-daily beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

  • FDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB) - December 23, 2020

Ebanga (ansuvimab-zykl) Injection

Company: Ridgeback Biotherapeutics, LP.
Date of Approval: December 21, 2020
Treatment for: Zaire Ebolavirus Infection

Ebanga (ansuvimab-zykl) is a monoclonal antibody for the treatment of Zaire ebolavirus (Ebolavirus) infection in adults and children.

  • FDA Approves Ebanga (ansuvimab-zykl) for the Treatment of Zaire Ebolavirus Infection - December 21, 2020

Orgovyx (relugolix) Tablets

Company: Myovant Sciences
Date of Approval: December 18, 2020
Treatment for: Prostate Cancer

Orgovyx (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.

  • FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer - December 18, 2020

Riabni (rituximab-arrx) Injection

Company:Amgen Inc.
Date of Approval: December 17, 2020
Treatment for: non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Wegener's Granulomatosis, Microscopic Polyangiitis

Riabni (rituximab-arrx) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA).

  • FDA Approves Riabni (rituximab-arrx), a Biosimilar to Rituxan - December 17, 2020

Margenza (margetuximab-cmkb) Injection

Company: MacroGenics, Inc.
Date of Approval: December 16, 2020
Treatment for: Breast Cancer

Margenza (margetuximab-cmkb) is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2- positive breast cancer.

  • FDA Approves Margenza (margetuximab-cmkb) for Patients with Pretreated Metastatic HER2-Positive Breast Cancer - December 16, 2020

Klisyri (tirbanibulin) Ointment

Phase 1 Launch Date 2020

Company: Athenex, Inc.
Date of Approval: December 14, 2020
Treatment for: Actinic Keratosis

Klisyri (tirbanibulin) is a first-in-class dual Src Kinase and tubulin polymerization inhibitor for the topical treatment of actinic keratosis on the face or scalp.

  • FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp - December 15, 2020

Orladeyo (berotralstat) Capsules

Company: BioCryst Pharmaceuticals, Inc.
Date of Approval: December 3, 2020
Treatment for: Hereditary Angioedema

Orladeyo (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

  • FDA Approves Orladeyo (berotralstat) as the First Oral, Once-Daily Therapy to Prevent Attacks in Hereditary Angioedema Patients - December 3, 2020

Ga 68 PSMA-11 Injection

Company: University of California, San Francisco
Date of Approval: December 1, 2020
Treatment for: Diagnostic

Ga 68 PSMA-11 Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

  • FDA Approves Gallium 68 PSMA-11 as the First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer - December 1, 2020

Danyelza (naxitamab-gqgk) Injection

Company: Y-mAbs Therapeutics, Inc.
Date of Approval: November 25, 2020
Treatment for: Neuroblastoma

Danyelza (naxitamab-gqgk) is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GMCSF), for the treatment of patients with relapsed or refractory high-risk neuroblastoma.

  • FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma - November 27, 2020
Phase 1 launch date 2

Imcivree (setmelanotide) Injection

Company: Rhythm Pharmaceuticals, Inc.
Date of Approval: November 25, 2020
Treatment for: Obesity

Launch

Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist for chronic weight management of obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency.

  • FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency - November 27, 2020

Oxlumo (lumasiran) Injection

Company:Alnylam Pharmaceuticals, Inc.
Date of Approval: November 23, 2020
Treatment for: Primary Hyperoxaluria Type 1 (PH1)

Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

  • FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1 - November 24, 2020

Zokinvy (lonafarnib) Capsules

Company: Eiger BioPharmaceuticals, Inc.
Date of Approval: November 20, 2020
Treatment for: Progeria and Progeroid Laminopathies

Zokinvy (lonafarnib) is an oral farnesyltransferase inhibitor (FTI) for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL).

  • FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies - November 20, 2020

Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets

Company:Sebela Pharmaceuticals, Inc.
Date of Approval: November 10, 2020
Treatment for: Bowel Preparation

Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) is an osmotic laxative in a tablet formulation indicated for cleansing the colon in preparation for colonoscopy in adults.

  • FDA Approves Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets for Colonoscopy Preparation - November 10, 2020

Sesquient (fosphenytoin sodium) for Injection

Company: Sedor Pharmaceuticals, LLC
Date of Approval: November 5, 2020
Treatment for: Status Epilepticus

Sesquient (fosphenytoin sodium for injection) is a Captisol-enabled™, room-temperature stable formulation of fosphenytoin sodium indicated for the treatment of status epilepticus in adults and children.

  • FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients - November 9, 2020

Bronchitol (mannitol) Inhalation Powder

Company: Chiesi USA, Inc.
Date of Approval: October 30, 2020
Treatment for: Cystic Fibrosis

Bronchitol (mannitol) is an inhaled dry powder formulation of the sugar alcohol mannitol indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis.

  • FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis - November 2, 2020

Eysuvis (loteprednol etabonate) Ophthalmic Suspension

Company: Kala Pharmaceuticals, Inc.
Date of Approval: October 26, 2020
Treatment for: Dry Eye Disease

Eysuvis (loteprednol etabonate) is an ophthalmic corticosteroid formulation for the temporary relief of signs and symptoms of dry eye disease.

  • FDA Approves Eysuvis (loteprednol etabonate) Ophthalmic Suspension for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease - October 27, 2020

Veklury (remdesivir) Injection

Company:Gilead Sciences, Inc.
Date of Approval: October 22, 2020
Treatment for:COVID-19

Veklury (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19 patients who require hospitalization.

  • FDA Approves Veklury (remdesivir) for the Treatment of COVID-19 - October 22, 2020

Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) Injection

Company:Regeneron Pharmaceuticals, Inc.
Date of Approval: October 14, 2020
Treatment for:Zaire Ebolavirus Infection

Inmazeb is (atoltivimab, maftivimab, and odesivimab) is a monoclonal antibody combination indicated for the treatment of Zaire ebolavirus infection in adults and children, including newborns of mothers who have tested positive for the virus.

  • FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus) - October 14, 2020
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© Provided by CBS Miami

MIAMI (CBSMiami) – There’s a light at the end of the COVID tunnel.

That’s according to Miami-Dade Mayor Carlos Gimenez who announced that they have set May 18th as the target date for a phase one reopening.

Under phase one, the mayor said some non-essential businesses and restaurants would be able to open with restrictions. He did not specify which businesses.

Business owners tell CBS4’s Peter D’Oench that the next phase can not happen soon enough.

Giancarlo Morera says business has dropped 50 percent at his family’s business, the Enriqueta’s Sandwich Shop in Miami since it had to offer only take-out food. The restaurant has been empty since then.

He said, “I have been looking forward to this next phase since the restrictions began. We have been missing customers, and that has hurt us a lot. We are only open at the window to take out, and we miss our customers. This has been really hard.” He said he hopes his restaurant will be included in Phase 1, which could resemble what CBS4 S saw on Monday when restaurants and businesses were allowed to open at 25 percent capacity with people at least 6 feet apart and groups of no more than 10 people.

Jon Popiel said he hopes to open up his F45 Training gym next to Enriqueta’s by mid-July and he welcomed the Mayor’s target date.

“Anyone in the industry wants this to happen sooner rather than later. We need to open up this economy and I look forward to that. I am a gym owner and I hope to be part of this first wave. Owners are hurting. People have everything invested in their business and while I realize people have reservations about coming out, we need to get the economy going again. I realize it is not going to happen overnight.”

Gimenez stressed that May 18 was a target date and some businesses still had some work to do in order to be ready.

“Tomorrow I will be meeting with our medical experts who worked with those groups. I have spoken to the governor who is in agreement that Miami-Dade should move forward in opening certain sectors of the economy,” said Gimenez.

Gimenez said at each step they will be following the recommendations of their medical experts including the Florida Department of Health, doctors from Jackson Health System, the medical schools of FIU and the University of Miami.

Phase 1 Launch Date 3

“We want to make sure our seniors and at-risk individuals are protected. We need to get the economy going again and do it as safely as possible,” he said.

“Most people who are testing positive show few symptoms and we are seeing a tamping down of hospitalizations,” he said. “We want to open up businesses safely and get people back to work. I think we continue to see a decline in the number of COVID-19 patients being hospitalized and the number of patients on ventilators.”

When asked if the county was ready for a phase one reopening, Gimenez said yes because the metrics were there to support it.

He stressed that no beaches will reopen under phase one.

Phase 1 Launch Date Countdown

WATCH: MAYOR CARLOS GIMENEZ VIRTUAL NEWS CONFERENCE

The mayor also announced that two drive-thru COVID-19 test sites would lower their minimum age to 12-years-old and up. Those under 17 must have parental approval.

The new age limit applies to the sites at both the Tamiami Fairgrounds and South Dade Government Center.

The 18-years and older criteria still applies to the drive-thru test sites at Marlins Park and the Holy Family Catholic Church in North Miami.

“For all those sites, you do not have to be experiencing symptoms to get tested. But you do have to call to make an appointment for testing the next day. County residents can call (305) 499-8767,” said Gimenez.

The mayor said that Jackson Health Urgent Care Centers throughout the county will be providing free testing at their locations.

“As we test more people, we expect to get more positive results but that doesn’t mean that people will end up in the hospital. In fact, most of the people who tested positive had few symptoms or, many of them, none at all. We continue to see a tamping down of hospitalizations. Yesterday’s hospital report shows 582 coronavirus patients throughout Miami-Dade County. That’s the lowest number of patients in the hospital since I first issued the emergency order number 18-20 on April 4th,” said Gimenez.

Phase 1 Launch Date Calendar Printable

The mayor said Mother’s Day is this weekend and reminded people to practice social distancing while visiting family members. Wear a face mask if you’re inside, he said, better yet if you have an outdoor space, celebrate there.

“We have a very clear picture of the problems we will face if we fail to do this. Two weeks after Easter and Passover, we saw a spike in the number of COVID-19 hospitalizations here in the county. This happened despite our warnings to stay safer at home. People are eager to see each other and they were so eager they broke the rules of social distancing. So please do not put your loved ones or our community in danger,” said Gimenez.

Broward Mayor Dale Holness is also eyeing May 18th. But he wants mayors and city managers all on the same page with the county.

“Retail, restaurants, barbershops, and beauty salons. Those things that people are in need of today,” the mayor said.

Phase 1 Launch Date 2020

City leaders have already weighed in on a survey and it gives an idea of what may open in Broward. Most agreed Retail should reopen with restrictions. Along with restaurants. Drive-in movie theaters may be included along with gyms at apartments and condos.

The Broward County mayor will have a phone conference with city mayors Monday afternoon.

Phase 1 Launch Date Template

“That’s one of the reasons we have been cautious. To ensure that we are not putting our people in danger and then having a spike or resurgence and closing down again,” Holness said.

Phase 1 Launch Date Software

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