برنامج تطوير مهنة الصيدلة - PPDPROGRAM
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PHARMACY PROFESSION DEVELOPMENT PROGRAM
PROF/MAHMOUD MAHYOOB ALBURYHI
PROFESSOR OF PHARMACEUTICS AND INDUSTRIAL PHARMACY, FACULTY OF PHARMACY, SANA'A UNIVERSITY, YEMEN.
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➡️Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) Suspension for Intramuscular Injection

Date of Approval: December 21, 2018
Company: Merck and Sanofi
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis, Poliomyelitis Prophylaxis, Hepatitis B Prevention, Haemophilus influenzae Prophylaxis

Vaxelis is a hexavalent combination vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b in children from 6 weeks through 4 years of age (prior to the 5th birthday).

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➡️Rhofade (oxymetazoline hydrochloride) Cream

Date of Approval: January 18, 2017
Company: Allergan plc
Treatment for: Rosacea

Rhofade (oxymetazoline hydrochloride) is a topical alpha1A adrenoceptor agonist vasoconstrictor for the treatment of persistent facial erythema associated with rosacea in adults.

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➡️AirDuo RespiClick (fluticasone propionate and salmeterol) Inhalation Powder

Date of Approval: January 27, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma, Maintenance

AirDuo RespiClick (fluticasone propionate and salmeterol) is a corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination in a breath-activated, multi-dose dry powder inhaler formulation for the treatment of asthma.

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➡️ArmonAir RespiClick (fluticasone propionate) Inhalation Powder

Date of Approval: January 27, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma, Maintenance

ArmonAir RespiClick (fluticasone propionate) is an inhaled corticosteroid in a breath-activated, multi-dose dry powder inhaler formulation for the treatment of asthma.

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➡️Parsabiv (etelcalcetide) Injection

Date of Approval: February 7, 2017
Company: Amgen Inc.
Treatment for: Secondary Hyperparathyroidism

Parsabiv (etelcalcetide) is a calcium-sensing receptor agonist indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

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➡️Emflaza (deflazacort) Tablets and Oral Suspension

Date of Approval: February 9, 2017
Company: PTC Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy

Emflaza (deflazacort) is a glucocorticoid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

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➡️Qtern (dapagliflozin and saxagliptin) Tablets

Date of Approval: February 27, 2017
Company: AstraZeneca
Treatment for: Diabetes, Type 2

Qtern (dapagliflozin and saxagliptin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor fixed-dose combination for the treatment of adult patients with type 2 diabetes.

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➡️Odactra (house dust mite allergen extract) Sublingual Tablets

Date of Approval: March 1, 2017
Company: ALK-Abelló A/S
Treatment for: House Dust Mite Allergies

Odactra (house dust mite allergen extract) is a sublingual allergy immunotherapy (SLIT) tablet indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis.

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➡️Rebinyn (coagulation factor IX (recombinant), glycopegylated) Injection

Date of Approval: May 31, 2017
Company: Novo Nordisk
Treatment for: Hemophilia B

Rebinyn (coagulation factor IX (recombinant), glycopegylated is an extended-half-life recombinant DNA-derived coagulation factor IX concentrate for the treatment and control of bleeding episodes in patients with hemophilia B.

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➡️Symjepi (epinephrine) Injection

Date of Approval: June 15, 2017
Company: Adamis Pharmaceuticals Corporation
Treatment for: Allergic Reactions

Symjepi (epinephrine) is a non-selective alpha and betaadrenergic receptor agonist in a single-dose, pre-filled syringe for use the emergency treatment of allergic reactions (Type I) including anaphylaxis.

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➡️Baxdela (delafloxacin) Tablets and Injection

Date of Approval: June 19, 2017
Company: Melinta Therapeutics
Treatment for: Skin and Structure Infection, Pneumonia

Baxdela (delafloxacin) is a fluoroquinolone antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria.

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➡️Endari (L-glutamine) Oral Powder

Date of Approval: July 7, 2017
Company: Emmaus Life Sciences Inc.
Treatment for: Anemia, Sickle Cell

Endari (L-glutamine) is orally-administered pharmaceutical grade L-glutamine (PGLG), an amino acid formulation to relieve pain, swelling and other complications of sickle cell anemia.

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➡️(benznidazole) Tablets

Date of Approval: August 29, 2017
Company: Chemo Research, S. L.
Treatment for: Chagas Disease

Benznidazole is an antiprotozoal indicated for the treatment of Chagas disease, or American trypanosomiasis, a parasitic infection caused by Trypanosoma cruzi.

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➡️Vabomere (meropenem and vaborbactam) Injection - formerly Carbavance

Date of Approval: August 29, 2017
Company: The Medicines Company
Treatment for: Urinary Tract Infection

Vabomere (meropenem and vaborbactam) is a carbapenem and beta-lactamase inhibitor combination for the treatment of complicated urinary tract infections (cUTIs).

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➡️CaroSpir (spironolactone) Oral Suspension

Date of Approval: August 4, 2017
Company: CMP Pharma, Inc.
Treatment for: Heart Failure, Edema, High Blood Pressure

CaroSpir (spironolactone) is an oral suspension formulation of the potassium-sparing diuretic spironolactone indicated for the treatment of heart failure, management of edema, and for use as an add-on therapy in the treatment of hypertension.

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➡️KedRAB (rabies immunoglobulin human) Injection

Date of Approval: August 23, 2017
Company: Kamada Ltd. and Kedrion S.p.A.
Treatment for: Rabies Prophylaxis

KedRAB [rabies immunoglobulin (human)] is a human plasma derived anti-rabies immunoglobulin indicated for post-exposure prophylaxis (PEP) of rabies infection.

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➡️Solosec (secnidazole) Oral Granules

Date of Approval: September 15, 2017
Company: Lupin Pharmaceuticals, Inc.
Treatment for: Bacterial Vaginosis, Trichomoniasis

Solosec (secnidazole) is a nitroimidazole antimicrobial for use as a single-dose oral therapy in the treatment of bacterial vaginosis (BV) and trichomoniasis.

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➡️Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) Inhalation Powder

Date of Approval: September 18, 2017
Company: GlaxoSmithKline
Treatment for: COPD, Asthma, Maintenance

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA), and long-acting beta2-adrenergic agonist (LABA) combination indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), and the maintenance treatment of asthma in patients aged 18 years and older.

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➡️Xhance (fluticasone propionate) Nasal Spray - formerly OPN-375

Date of Approval: September 18, 2017
Company: OptiNose US Inc.
Treatment for: Nasal Polyps

Xhance (fluticasone propionate) is a topical nasal corticosteroid indicated for the treatment of nasal polyps.

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➡️Fiasp (insulin aspart) Injection

Date of Approval: September 29, 2017
Company: Novo Nordisk
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Fiasp (insulin aspart) is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Fiasp is a newer formulation of NovoLog, in which the addition of niacinamide (vitamin B3) helps to increase the speed of initial insulin absorption.

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