Publishing the Full Text of the Letter from FDA Containing the "List of VAT-Exempt Diabetes, High-Cholesterol and Hypertension Drugs" Pursuant to JAO No. 2-2018

January 10, 2019 REVENUE MEMORANDUM CIRCULAR NO. 004-19 SUBJECT : Publishing the Full Text of the Letter from the Food and Drug Administration (FDA) containing the "List of VAT-Exempt Diabetes, High-Cholesterol and Hypertension Drugs" Pursuant to Joint Administrative Order (JAO) No. 2-2018 Entitled "Implementing Guidelines on the Value-Added Tax (VAT) Exemption of the Sale of Drugs Prescribed for Diabetes, High-Cholesterol and Hypertension under Republic Act No. 8424 Otherwise Known as the National Internal Revenue Code of 1997, as Amended by Republic Act No. 10963" TO : All Internal Revenue Officials, Employees and Others Concerned For the information and guidance of all internal revenue officials and others concerned, attached is the letter dated January 10, 2019 from Atty. Katherine M. Austria-Lock, OIC-Center for Drug Regulation and Research, FDA, and the copy of the "List of VAT-exempt Diabetes, High-Cholesterol and Hypertension Drugs" in compliance to JAO No. 2-2018. HTcADC All concerned are hereby enjoined to be guided accordingly and give this Circular as wide a publicity as possible. Date Issued: January 15, 2019. (SGD.) CAESAR R. DULAY Commissioner of Internal Revenue ATTACHMENT January 9, 2019 Drugs used in Diabetes (A10) Insulins and Analogues (A10A) 1.Insulin (human): 100 I.U./mL Solution for Injection (I.M./S.C./I.V.); Solution for Injection (S.C./I.V.); Solution for Injection (S.C.); Suspension for Injection (S.C.) a.Biphasic insulin b.Biphasic Isophane Human Insulin c.Human Regular Insulin d.Insulin human + Isophane Insulin Human e.Neutral Insulin Human + Isophane Insulin Human f.Recombinant Human Insulin 2. Insulin aspart 100 Units/mL Solution for Injection (S.C.) a.Insulin aspart b.Biphasic Insulin Aspart c.Biphasic Insulin Aspart 30 d.Biphasic Insulin Aspart 50 3.Insulin degludec 100 Units/mL Solution for Injection (S.C.) 4.Insulin degludec and Insulin aspart 100 Units/mL (70% Insulin Degludec/30% Insulin Aspart) Solution for Injection (S.C.) 5.Insulin degludec and Liraglutide 100 Units/3.6 mg per mL Solution for Injection (S.C.) 6.Insulin detemir 100 Units/mL Solution for Injection (S.C.) 7.Insulin glargine 100 Units/mL Solution for Injection (S.C.) 300 Units/mL 8.Insulin glargine and Lixisenatide 3.64 mg (equivalent to 100 Units of Insulin glargine/33 mcg per mL Solution) Solution for Injection (S.C.) 3.64 mg (equivalent to 100 Units of Insulin glargine/50 mcg per mL Solution) 9.Insulin glulisine 3.49 mg/mL (equivalent to 100 units/mL) Solution for Injection (S.C.) Solution for Injection (Subcutaneous/Continuous S.C. Pump Infusion/Intravenous) 10.Insulin lispro a.rDNA origin 100 Units/mL (3.5 mg/mL) Solution for Injection (I.V./S.C./I.M.) b.50% Insulin Lispro and 50% Insulin-Lispro-Protamine Sulfate Suspension for Injection (S.C.) c.25% Insulin Lispro and 75% Insulin-Lispro-Protamine Sulfate Blood Glucose Lowering Drugs, excluding Insulins (A10B) A.Biguanides (A10BA) 1.Metformin 500 mg Tablet Film-Coated Tablet Extended-Release Tablet Sustained-Release Capsule Oral Solution 750 mg Extended-Release Tablet 850 mg Tablet Film-Coated Tablet Extended-Release Tablet Oral Solution 1,000 mg Tablet Film-Coated Tablet Extended-Release Tablet Sustained-Release Capsule Oral Solution B.Sulfonylureas (A10BB) 1.Glibenclamide 5 mg Tablet 2.Glipizide 2.5 mg Tablet Extended-Release Tablet 5 mg Tablet Extended-Release Tablet Controlled-Release Tablet 10 mg Extended-Release Tablet Controlled-Release Tablet 3.Gliclazide 30 mg Modified-Release Tablet Prolonged-Release Tablet 60 mg Modified-Release Tablet 80 mg Tablet Modified-Release Tablet 4.Glimepiride 1 mg Tablet; Film-Coated Tablet 2 mg 3 mg 4 mg C.Combinations of oral blood glucose lowering drugs (A10BD) 1.Metformin and Sulfonylureas a.Metformin and Glipizide 500 mg + 5 mg Tablet b.Metformin and Gliclazide 500 mg + 80 mg Film-Coated Tablet 850 mg + 80 mg c.Metformin and Glimepiride 500 mg + 1 mg Tablet 500 mg + 2 mg Tablet Film-Coated Tablet Sustained-Release Capsule Extended-Release Tablet Prolonged-Release Tablet 1 g + 2 mg Tablet d.Metformin and Glibenclamide 250 mg + 1.25 mg Film-Coated Tablet 500 mg + 2.5 mg 500 mg + 5 mg 500 mg + 5mg Tablet 1 g + 5 mg 2.Metformin and Pioglitazone 500 mg + 15 mg Film-Coated Tablet 850 mg +15 mg 3.Glimepiride and Pioglitazone 15 mg/2 mg Tablet 30 mg/2 mg 4.Metformin and Sitagliptin 50 mg + 500 mg Tablet Film-Coated Tablet 50 mg + 850 mg Tablet 50 mg + 1,000 mg Tablet 50 mg + 1 g Film-Coated Tablet 100 mg + 1 g Extended-Release Tablet 5.Metformin and Vildagliptin 50 mg + 500 mg Film-Coated Tablet 50 mg + 850 mg 50 mg + 1,000 mg 6.Pioglitazone and Alogliptin 12.5 mg/15 mg Film-Coated Tablet 12.5 mg/30 mg 25 mg/15 mg 25 mg/30 mg 7.Metformin and Saxagliptin 2.5 mg/1 g Film-Coated Tablet 5 mg/500 mg 5 mg/1 g 8.Metformin and Linagliptin 2.5 mg + 500 mg Film-Coated Tablet 2.5 mg + 850 mg 2.5 mg + 1,000 mg 9.Metformin and Dapagliflozin 5 mg/500 mg Tablet 5 mg/1,000 mg 10 mg/500 mg 10 mg/1,000 mg 10.Linagliptin and Empagliflozin 10 mg/5 mg Film-Coated Tablet 25 mg/5 mg 11.Metformin and Empagliflozin 5 mg/500 mg Film-Coated Tablet 5 mg/850 mg 5 mg/1 g 12.5 mg/500 mg 12.5 mg/850 mg 12.5 mg/1 g 12.Pioglitazone, Metformin and Glimepiride** 15 mg/500 mg/1 mg Film-Coated Tablet 15 mg/500 mg/2 mg 13.Saxagliptin and Dapagliflozin 5 mg/10 mg Film-Coated Tablet D.Alpha glucosidase inhibitors (A10BF) 1.Acarbose 50 mg Tablet Film-Coated Tablet 100 mg Tablet 2.Voglibose 200 mcg Tablet Orally Disintegrating Tablet 300 mcg Tablet Dispersible Tablet E.Thiazolidinediones (A10BG) 1.Pioglitazone 15 mg Tablet Film-Coated Tablet 30 mg Tablet 45 mg Tablet F.Dipeptidyl peptidase 4 (DPP-4) inhibitors (A10BH) 1.Sitagliptin 25 mg Film-Coated Tablet 50 mg 100 mg 2.Vildagliptin 50 mg Tablet 3.Saxagliptin 2.5 mg Film-Coated Tablet 5 mg 4.Linagliptin 5 mg Tablet 5.Gemigliptin 50 mg Film-Coated Tablet 6.Sitagliptin and Simvastatin 100 mg + 10 mg Film-Coated Tablet 100 mg + 20 mg 100 mg + 40 mg G.Glucagon-like peptide-1 (GLP-1) analogues (A10BJ) 1.Exenatide 2 mg Powder for Suspension for Injection (S.C.) 250 mcg/mL (5 mcg/dose) Solution for Injection (S.C.) 250 mcg/mL (10 mcg/dose) 2.Liraglutide 6 mg/mL Solution for Injection (S.C.) 3.Lixisenatide 10 mcg + 0.2 mL (0.15 mg/3 mL) Solution for Injection (S.C.) 20 mcg + 0.2 mL H.Sodium-glucose co-transporter 2 (SGLT2) inhibitors (A10BK) 1.Dapagliflozin 5 mg Tablet 10mg 2.Canagliflozin 100 mg Film-Coated Tablet 300 mg 3.Empagliflozin 10 mg Film-Coated Tablet 25 mg I.Other blood glucose lowering drugs, excluding insulins 1.Repaglinide 500 mcg Tablet 1 mg 2 mg 2.Nateglinide 120 mg Film-Coated Tablet LIPID MODIFYING AGENTS A.LIPID MODIFYING AGENTS, PLAIN A.1HMG CoA REDUCTASTE INHIBITORS Generic Name Strength Dosage Form Simvastatin 5mg Tablet, Film-coated tablet 10mg 20mg 40mg 80mg Simvastatin + Ubidecarenone (CoQ10) 20mg/10mg Capsule Sitagliptin (as Phosphate) + Simvastatin 100mg/10mg Film-coated tablet 100mg/20mg 100mg/40mg Pravastatin (as Sodium) 20mg Tablet 40mg Fluvastatin (as Sodium) 80mg Tablet, Film-coated Atorvastatin, Atorvastatin (as Calcium) 5mg Tablet, Film-coated tablet 10mg 20mg 40mg 80mg Atorvastatin (as calcium propylene glycol solvate) 10mg Film-coated tablet 20mg 40mg 80mg Atorvastatin (as calcium trihydrate) 10mg Tablet, Film-coated tablet 20mg 40mg 80mg Atorvastatin + Fenofibrate 10mg/160mg Tablet, Film-coated 20mg/160mg Clopidogrel (as bisulfate) + Rosuvastatin (as Calcium) 75mg/10mg Capsule 75mg/20mg Rosuvastatin 10mg Tablet, Film-coated tablet 20mg Rosuvastatin (as Calcium) 5mg Tablet, Film-coated tablet 10mg 20mg 40mg Rosuvastatin (as calcium) + Fenofibrate 10mg/160mg Tablet, Film-coated tablet 20mg/160mg 10mg/145mg Rosuvastatin (as Zinc) 20mg Film-coated tablet Pitavastatin calcium 2mg Tablet, Film-coated tablet 4mg A.2FIBRATES Gemfibrozil 300mg Capsule, Tablet, Film-coated tablet 600mg 900mg Fenofibrate 145mg Tablet, Capsule, Film-coated tablet 160mg Tablet, Capsule, Film-coated tablet 200mg Capsule, Micronized capsule 300mg Capsule 100mg Capsule 250mg Capsule, Sustained-release capsule 67mg Capsule Ciprofibrate 100mg Tablet, Capsule A.3BILE ACID SEQUESTRANTS No registered drug under this category A.4NICOTINIC ACID DERIVATIVES Nicotinic Acid 50mg Tablet 100mg Tablet 500mg Tablet, Extended release tablet A.5OTHER LIPID MODIFYING AGENTS Probucol 250mg Tablet Eicosapentaenoic Acid + Docosahexaenoic Acid 460mg/380mg Capsule, Soft gelatin capsule Eicossapentaenoic Acid (Epa) Ethyl Ester + Docosahexaenoic Acid (Dha) Ethyl Ester 460mg + 380mg Capsule, Soft gelatin capsule Ezetimibe 10mg Tablet Evolocumab 140mg/mL Solution for injection, Solution for injection SC Alirocumab 75mg/mL Solution for injection SC 150mg/mL Solution for injection SC B.LIPID MODIFYING AGENTS, COMBINATIONS B.1HMG CoA REDUCTASE INHIBITORS IN COMBINATION WITH OTHER LIPID MODIFYING AGENTS Ezetimibe + Simvastatin 10mg/10mg Tablet, Film-coated tablet 10mg/20mg 10mg/40mg Fenofibrate + Simvastatin 145mg/20mg Film-coated tablet 145mg/40mg 160mg/10mg 160mg/20mg Fenofibrate + Pravastatin Sodium 160mg/40mg Capsule Ezetimibe + Atorvastatin 10mg/10mg Film-coated tablet 10mg/20mg 10mg/40mg 10mg/80mg B.2HMG CoA REDUCTASE INHIBITORS, OTHER COMBINATIONS Amlodipine (as besilate) + Atorvastatin (as Calcium) 5mg/10mg Tablet, Film-coated table 5mg/20mg 5mg/40mg 10mg/10mg 10mg/20mg 10mg/40mg 10mg/80mg Atorvastatin (as calcium trihydrate) + Amlodipine (as besilate) 20mg/5mg Tablet, Film-coated tablet 20mg/10mg 10mg/5mg Atorvastatin + Perindopril (as arginine) + Amlodipine (as besilate) 10mg/5mg/5mg Film-coated tablet 20mg/5mg/5mg 20mg/10mg/5mg 20mg/10mg/10mg 40mg/10mg/10mg Aspirin + Rosuvastatin 80mg/10mg Capsule 80mg/20mg ANTI-HYPERTENSIVES A.ANTI-HYPERTENSIVES GENERIC NAME DOSAGE STRENGTH DOSAGE FORM Methyldopa 125 mg Tablet 250 mg Tablet Film-Coated Tablet Clonidine 75 mcg 150 mcg Tablet 150 mcg/mL Solution for Injection (IM/IV/SC) Doxazosin 4 mg Controlled-Release Tablet Hydralazine 25 mg Film-Coated Tablet 50 mg Tablet 20 mg/mL Solution for Injection (IM/IV) Sodium nitroprusside 50 mg Lyophilized Powder for Injection (IV) Bosentan 125 mg Tablet Film-Coated Tablet Ambrisentan 5 mg Film-Coated Tablet Macitentan 10 mg Film-Coated Tablet B.DIURETICS Hydrochlorothiazide 12.5 mg, 25 mg Tablet Film-Coated Tablet 50 mg Tablet Metolazone 5 mg Tablet Indapamide 1.5 mg Tablet Sustained-Release Tablet Furosemide 20 mg 40 mg Tablet 10 mg/mL (20 mg/2 mL) Solution for Injection (IM/IV) Bumetanide 1 mg Tablet 500 mcg/mL Solution for Injection (IM/IV) Torasenide 5 mg 10 mg Prolonged-Release Tablet Furosemide + Potassium chloride 40 mg + 600 mg Film-Coated Tablet Spironolactone 25 mg 50 mg 100 mg Tablet Film-Coated Tablet Eplerenone 25 mg 50 mg Film-Coated Tablet Hydroflumethiazide + Spironolactone 25 mg + 25 mg Film-Coated Tablet Tolvaptan 15 mg Tablet C.BETA BLOCKING AGENTS Pindolol 5 mg Tablet Propranolol 10 mg, 40 mg Tablet Film-Coated Tablet Metoprolol 50 mg Tablet Film-Coated Tablet Extended-Release Tablet Powder for Injection (IM/IV) 100 mg Tablet Film-Coated Tablet Extended-Release Tablet 23.75 mg Controlled-Release Tablet 47.5 mg Extended-Release Tablet 95 mg Controlled-Release Tablet Extended-Release Tablet Atenolol 25 mg 50 mg 100 mg Tablet Film-Coated Tablet Betaxolol 20 mg Film-Coated Tablet Bisoprolol 2.5 mg 10 mg Film-Coated Tablet 5 mg Tablet Film-Coated Tablet Esmolol 10 mg/mL (100 mg/10 mL) Solution for Injection (IV) Nebivolol 2.5 mg 5 mg Tablet Labetalol 5 mg/mL (100 mg/20 mL) Solution for Injection/Infusion (IV) Carvedilol 3.125 mg Film-Coated Tablet 6.25 mg, 12.5 mg Tablet Film-Coated Tablet 10 mg 20 mg 40 mg 80 mg Extended-Release Capsule Atenolol + Chlortalidone 50 mg + 12.5 mg Tablet Bisoprolol + Hydrochlorothiazide 2.5 mg + 6.25 mg 5 mg + 6.25 mg 10 mg + 6.25 mg Film-Coated Tablet Nebivolol + Hydrochlorothiazide 5 mg + 12.5 mg Tablet Metoprolol + Felodipine 50 mg + 5 mg Extended-Release Tablet Bisoprolol + Amlodipine 5 mg + 5 mg 5 mg + 10 mg 10 mg + 5 mg 10 mg + 10 mg Tablet Metoprolol + Ivabradine 25 mg + 5 mg 25 mg + 7.5 mg 50 mg + 5 mg 50 mg + 7.5 mg Film-Coated Tablet D.CALCIUM CHANNEL BLOCKERS Amlodipine 2.5 mg Tablet 5 mg, 10 mg Tablet Film-Coated Tablet Felodipine 2.5 mg Extended-Release Tablet 5 mg Tablet Extended-Release Tablet Modified-Release Tablet 10 mg Extended-Release Tablet Modified-Release Tablet Nicardipine 1 mg/mL (2 mg/2 mL, 10 mg/10 mL) Solution for Injection/Infusion (IV) Nifedipine 5 mg, 10 mg Capsule Softgel Capsule 20 mg Tablet Extended-Release Tablet Sustained-Release Tablet 30 mg Retard Tablet Extended-Release Tablet Prolonged-Release Tablet 60 mg Prolonged-Release Tablet Lacidipine 2 mg, 4 mg Tablet Film-Coated Tablet 6 mg Tablet Manidipine 10 mg 20 mg Tablet Lercanidipine 10 mg, 20 mg Tablet Film-Coated Tablet Verapamil 40 mg Film-Coated Tablet 80 mg Tablet Film-Coated Tablet 180 mg Tablet Sustained-Release Tablet 240 mg Film-Coated Tablet Sustained-Release Tablet 2.5 mg/mL (5 mg/2 mL) Solution for Injection (IV) Verapamil + Trandolapril 180 mg/2 mg Film-Coated Tablet Amlodipine + Hydrochlorithiazide 5 mg/12.5 mg 10 mg/12.5 mg Tablet E.AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM Captopril 25 mg Tablet Film-Coated Tablet 50 mg Tablet Enalapril 5 mg, 20 mg Tablet Film-Coated Tablet 10 mg Tablet Lisinopril 5 mg 10 mg 20 mg Tablet Perindopril 2 mg 8 mg Tablet 4 mg Tablet Film-Coated Tablet 5 mg 10 mg Film-Coated Tablet Ramipril 2.5 mg, 5 mg Tablet Film-Coated Tablet 10 mg Tablet Quinapril 5 mg Tablet 10 mg, 20 mg Tablet Film-Coated Tablet Benazepril 10 mg Film-Coated Tablet Fosinopril 10 mg 20 mg Tablet Zofenopril 7.5 mg 30 mg Film-Coated Tablet Imidapril 5 mg 10 mg Tablet Enalapril + Hydrochlorothiazide 10 mg + 12.5 mg 10 mg + 25 mg 20 mg + 12.5 mg Tablet Lisinopril + Hydrochlorothiazide 10 mg + 12.5 mg 20 mg + 12.5 mg Tablet Perindopril + Indapamide 2 mg + 625 mcg Tablet 4 mg + 1.25 mg Tablet Film-Coated Tablet 5 mg + 1.25 mg 10 mg + 2.5 mg Film-Coated Tablet Ramipril + Hydrochlorothiazide 5 mg + 25 mg Tablet Quinapril + Hydrochlorothiazide 20 mg + 12.5 mg Tablet Perindopril + Amlodipine 3.5 mg + 2.5 mg 5 mg + 5 mg 5 mg + 10 mg 7 mg + 5 mg 10 mg + 5 mg 10 mg + 10 mg Tablet Trandolapril + Verapamil 2 mg + 180 mg Film-Coated Tablet Perindopril + Indapamide + Amlodipine 2.5 mg + 625 mcg + 5 mg 5 mg + 1.25 mg + 5 mg 5 mg + 1.25 mg + 10 mg 10 mg + 2.5 mg +5 mg 10 mg + 2.5 mg + 10 mg Film-Coated Tablet Losartan 25 mg Film-Coated Tablet 50 mg, 100 mg Tablet Film-Coated Tablet Valsartan 40 mg, 320 mg Tablet Film-Coated Tablet 80 mg 160 mg Tablet Film-Coated Tablet Capsule Irbesartan 75 mg Film-Coated Tablet 150 mg, 300 mg Tablet Film-Coated Tablet Candesartan 4 mg 8 mg 16 mg Tablet Telmisartan 20 mg 40 mg 80 mg Tablet Film-Coated Tablet Olmesartan 10 mg Film-Coated Tablet 20 mg, 40 mg Tablet Film-Coated Tablet Azilsartan 40 mg 80 mg Tablet Fimasartan 60 mg 120 mg Film-Coated Tablet Losartan + Hydrochlorothiazide 25 mg +12.5 mg 100 mg + 12.5 mg Film-Coated Tablet 50 mg + 12.5 mg 100 mg + 12.5 mg Tablet Film-Coated Tablet Eprosartan + Hydrochlorothiazide 600 mg + 12.5 mg Film-Coated Tablet Valsartan + Hydrochlorothiazide 80 mg + 25 mg Film-Coated Tablet 80 mg + 12.5 mg 160 mg + 12.5 mg 160 mg + 25 mg 320 mg + 12.5 mg 320 mg + 25 mg Tablet Film-Coated Tablet Irbesartan + Hydrochlorothiazide 150 mg + 12.5 mg 300 mg + 12.5 mg Tablet Film-Coated Tablet 300 mg + 25 mg Film-Coated Tablet Candesartan + Hydrochlorothiazide 16 mg + 12.5 mg Tablet Telmisartan + Hydrochlorothiazide 20 mg + 12.5 mg 80 mg + 25 mg Tablet 40 mg + 12.5 mg 80 mg + 12.5 mg Tablet Film-Coated Tablet Olmesartan + Hydrochlorothiazide 20 mg + 12.5 mg 40 mg + 12.5 mg Film-Coated Tablet Valsartan + Amlodipine 5 mg + 80 mg 5 mg + 160 mg 10 mg + 160 mg Tablet Film-Coated Tablet Olmesartan medoxomil + Amlodipine 20 mg + 5 mg 20 mg + 10 mg 40 mg + 5 mg 40 mg + 10 mg Film-Coated Tablet Telmisartan + Amlodipine 40 mg + 5 mg 40 mg + 10 mg 80 mg + 5 mg 80 mg + 10 mg Tablet Losartan + Amlodipine 25 mg + 5 mg Tablet 50 mg + 5 mg 100 mg + 5 mg Tablet Film-Coated Tablet 100 mg + 10 mg Film-Coated Tablet Candesartan + Amlodipine 8 mg + 5 mg Tablet Amlodipine + Valsartan + Hydrochlorothiazide 5 mg + 160 mg + 12.5 mg 5 mg + 160 mg + 25 mg 10 mg + 160 mg + 12.5 mg 10 mg + 160 mg + 25 mg 10 mg + 320 mg + 25 mg Film-Coated Tablet Olmesartan medoxomil + Amlodipine + Hydrochlorothiazide 20 mg + 5 mg + 12.5 mg Film-Coated Tablet Aliskiren + Amlodipine 150 mg + 5 mg 300 mg + 5 mg Film-Coated Tablet