➡️Ziextenzo (pegfilgrastim-bmez) Injection

Date of Approval: November 4, 2019
Company: Sandoz
Treatment for: Neutropenia Associated with Chemotherapy

Ziextenzo (pegfilgrastim-bmez) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim) used to reduce the incidence of febrile neutropenia in patients treated with chemotherapy.


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➡️Reblozyl (luspatercept-aamt) for Injection

Date of Approval: November 8, 2019
Company: Celgene Corporation
Treatment for: Anemia in Beta-Thalassemia; Anemia in Lower-Risk Myelodysplastic Syndromes

Reblozyl (luspatercept-aamt) is a first-in-class erythroid maturation agent (EMA) for the treatment of:

Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

Limitations of Use: Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

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➡️Fetroja (cefiderocol) Injection

Date of Approval: November 14, 2019
Company: Shionogi & Co., Ltd.
Treatment for: Complicated Urinary Tract Infections; Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia

Fetroja (cefiderocol) is a siderophore cephalosporin indicated for the treatment of complicated urinary tract infections (cUTI), hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible Gram-negative microorganisms.

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➡️Givlaari (givosiran) Injection

Date of Approval: November 20, 2019
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Acute Hepatic Porphyria

Givlaari (givosiran) is an aminolevulinate synthase 1-directed small interfering RNA (siRNA) indicated for the treatment of adults with acute hepatic porphyria (AHP).

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➡️Xcopri (cenobamate) Tablets

Date of Approval: November 21, 2019
Company: SK Life Science, Inc.
Treatment for: Seizures

Xcopri (cenobamate) is an antiepileptic drug for the treatment of partial-onset seizures in adult patients.

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➡️Oxbryta (voxelotor) Tablets

Date of Approval: November 25, 2019
Company: Global Blood Therapeutics, Inc.
Treatment for: Anemia, Sickle Cell

Oxbryta (voxelotor) is an oral, HbS (sickle hemoglobin) polymerization inhibitor for the treatment of patients with sickle cell disease (SCD).

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➡️Nouress (cysteine hydrochloride) Injection

Date of Approval: December 13, 2019
Company: Avadel Pharmaceuticals plc
Treatment for: Total Parenteral Nutrition

Nouress (cysteine hydrochloride) is a sulfur-containing amino acid indicated for use as an additive to amino acid solutions to meet nutritional requirements of neonates requiring total parenteral nutrition.

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➡️Arazlo (tazarotene) Lotion

Date of Approval: December 18, 2019
Company: Bausch Health Companies Inc.
Treatment for: Acne

Arazlo (tazarotene) is a lotion formulation of the approved retinoid tazarotene for the topical treatment of acne vulgaris in patients 9 years of age and older.

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➡️Caplyta (lumateperone) Capsules

Date of Approval: December 20, 2019
Company: Intra-Cellular Therapies, Inc.
Treatment for: Schizophrenia, Bipolar Disorder

Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia and bipolar depression.

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➡️Dayvigo (lemborexant) Tablets

Date of Approval: December 20, 2019
Company: Eisai Co., Ltd.
Treatment for: Insomnia

Dayvigo (lemborexant) is dual orexin receptor antagonist (DORA) for the treatment of insomnia.

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➡️Firvanq (vancomycin hydrochloride) for Oral Solution

Date of Approval: January 26, 2018
Company: CutisPharma
Treatment for: Clostridium Difficile Associated Diarrhea; Enterocolitis

Firvanq (vancomycin hydrochloride) is an oral solution formulation of an approved tricyclic glycopeptide antibiotic for the treatment of Clostridium difficile associated diarrhea and Staphylococcus aureus enterocolitis.

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➡️ZTlido (lidocaine) Patch - formerly Ztilido

Date of Approval: February 28, 2018
Company: Scilex Pharmaceuticals, Inc.
Treatment for: Postherpetic Neuralgia

ZTlido (lidocaine topical system 1.8%) is a transdermal anesthetic formulation for the treatment of pain associated with postherpetic neuralgia.

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➡️Akynzeo for Injection (fosnetupitant and palonosetron)

Date of Approval: April 19, 2018
Company: Helsinn
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Akynzeo for Injection (fosnetupitant and palonosetron) is a substance P/neurokinin-1 (NK-1) receptor antagonist and serotonin-3 (5-HT3) receptor antagonist combination indicated for use with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV).


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➡️Plenvu (polyethylene glycol 3350 with electrolytes) for Oral Solution

Date of Approval: May 4, 2018
Company: Salix Pharmaceuticals, Inc.
Treatment for: Bowel Preparation

Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride) is a lower-volume, polyethylene glycol based osmotic laxative indicated for cleansing of the colon (bowel preparation) prior to colonoscopy.

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➡️Lucemyra (lofexidine hydrochloride) Tablets

Date of Approval: May 16, 2018
Company: US WorldMeds
Treatment for: Opiate Withdrawal

Lucemyra (lofexidine hydrochloride) is a selective alpha 2-adrenergic receptor agonist indicated for reducing the severity of withdrawal symptoms in patients experiencing opioid withdrawal.

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➡️Lokelma (sodium zirconium cyclosilicate) for Oral Suspension

Date of Approval: May 18, 2018
Company: AstraZeneca
Treatment for: Hyperkalemia

Lokelma (sodium zirconium cyclosilicate) is a potassium binder indicated for the treatment of hyperkalemia in adults.

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➡️Palynziq (pegvaliase-pqpz) Injection

Date of Approval: May 24, 2018
Company: BioMarin Pharmaceutical Inc.
Treatment for: Phenylketonuria

Palynziq (pegvaliase-pqpz) is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria.

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➡️Consensi (amlodipine and celecoxib) Tablets

Date of Approval: May 31, 2018
Company: Kitov Pharma Ltd.
Treatment for: High Blood Pressure, Osteoarthritis

Consensi (amlodipine and celecoxib) is a calcium channel blocker and nonsteroidal anti-inflammatory drug combination for the treatment of both hypertension and pain associated with osteoarthritis.

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➡️Olumiant (baricitinib) Tablets

Date of Approval: May 31, 2018
Company: Eli Lilly and Company and Incyte Corporation
Treatment for: Rheumatoid Arthritis, COVID-19, Alopecia

Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, COVID-19, and alopecia areata.

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➡️Nocdurna (desmopressin acetate) Sublingual Tablets

Date of Approval: June 21, 2018
Company: Ferring Pharmaceuticals Inc.
Treatment for: Nocturia

Nocdurna (desmopressin acetate) is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults.

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➡️Zemdri (plazomicin) Injection

Date of Approval: June 25, 2018
Company: Achaogen, Inc.
Treatment for: Urinary Tract Infection

Zemdri (plazomicin) is an aminoglycoside antibacterial for the treatment of complicated urinary tract infections.


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