Publishing the Full Text of the April 26, 2022 Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) Endorsing Updates to the List of VAT-Exempt Medicines under Republic Act (R.A.) No. 11534 Known as the Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act

May 4, 2022 REVENUE MEMORANDUM CIRCULAR NO. 68-2022 SUBJECT : Publishing the Full Text of the April 26, 2022 Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) Endorsing Updates to the List of VAT-Exempt Medicines under Republic Act (R.A.) No. 11534 Known as the Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act TO : All Internal Revenue Officers and Others Concerned For the information and guidance of all internal revenue officers, employees and others concerned, attached is the April 26, 2022 letter (Annex "A") from Dr. Oscar G. Gutierrez, Jr., OIC-Director General of the FDA, for the inclusion of certain medicines prescribed for hypertension, diabetes, high cholesterol, kidney diseases, mental illness, tuberculosis, cancer, and COVID-19 treatment to the List of VAT-Exempt Medicines under R.A. No. 11534 or the CREATE Act. All concerned are hereby enjoined to be guided accordingly and give this Circular as wide a publicity as possible. CAESAR R. DULAY Commissioner of Internal Revenue By: (SGD.) MARISSA O. CABREROS Deputy Commissioner Legal Group Officer-in-Charge ANNEX A Department of Health FOOD AND DRUG ADMINISTRATION April 26, 2022 CAESAR R. DULAY Commissioner Bureau of Internal Revenue Quezon City SUBJECT : Endorsement of Updated List of VAT-Exempt Medicines under Republic Act (RA) 11534 known as Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act Dear Commissioner Dulay: With reference to the Implementing Guidelines on the Value-Added Tax (VAT) Exemption on Several Health Products provided under Joint Administrative Order (JAO) No. 2-2018 dated 21 December 2018 and JAO No. 2021-0001 dated 23 June 2021, may we provide you with the updates to the "List of VAT-Exempt Drugs for Hypertension, Cancer, Mental Illnesses, Tuberculosis, Kidney Diseases, Diabetes, and High Cholesterol." Further, DOH Department Memorandum No. 2021-0280 has been issued, wherein all documents with reference to the VAT-Exempt list of all COVID-19 related medicines and medical devices shall be forwarded to the FDA. Listed hereunder are the updates. I. A. Generic Name Dosage Strength Dosage Form Furosemide 10 mg/mL Solution for Injection (IM/IV) Irbesartan 75 mg Tablet Labetalol Hydrochloride 5 mg/mL (100 mg/20 mL) Solution for Injection (IV) Levandodipine (as besilate) 5 mg Tablet Levandodipine (as besilate) 2.5 mg Tablet Nebivolol (as hydrochloride) + Amlodipine (as besilate) 5 mg/5 mg Tablet Telmisartan + Amlodipine (as besilate) 80 mg/5 mg Tablet Telmisartan + Amlodipine (as besylate) 80 mg/5 mg Tablet B. Generic Name Dosage Strength Dosage Form ILLEGIBLE + Metformin Hydrochloride (In Sustained-Release Form) 2 mg/50 ILLEGIBLE Tablet Luseogliflozin (as hydrate) 5 mg Film-Coated Tablet Luseogliflozin (as hydrate) 2.5 mg Film-Coated Tablet Sitagliptin (as phosphate monohydrate) 25 mg Film-Coated Tablet C. Generic Name Dosage Strength Dosage Form Fenofibrate + Rosuvastatin (as calcium) 160 mg/10 mg Film-Coated Tablet Fenofibrate + Rosuvastatin (as calcium) 160 mg/20 mg Film-Coated Tablet Rosuvastatin (as zinc) + Ezetimibe 10 mg/10 mg Capsule Rosuvastatin (as zinc) + Ezetimibe 20 mg/10 mg Capsule D. Generic Name Dosage Strength Dosage Form Ketoanalogues + Essential Amino Acids Formulation: Each film-coated tablet contains Calcium-3-methyl-2-oxo-valerate 67 mg (a-Ketoanalogue to Isoleucine, calcium salt) Calcium-4-methyl-2-Oxo-valerate 101 mg (C-Ketoanalogue to Leucine, calcium salt) Calcium 2-oxo-3-Phenylpropionate 68 mg (a-Ketoanalogue to Phenylalanine, calcium salt) Calcium-3-methyl-2-oxo-butyrate 86 mg (a-Ketoanalogue to Valine, calcium salt) Film-Coated Tablet E. Generic Name Dosage Strength Dosage Form Citicoline 250 mg/mL Solution for Injection (IM/IV) Citicoline 500 mg Film-Coated Tablet Pregabalin 50 mg Capsule Rivastigmine 18 mg/10 cm2 (9.5mg/24 hours) Transdermal Patch Rivastigmine 9 mg/5 cm (4.6 mg/24 hours) Transdermal Patch Vortioxetine (as hydrobromide) 5 mg Film-Coated Tablet Vortioxetine (as hydrobromide) 10 mg Film-Coated Tablet Vortioxetine (as hydrobromide) 15 mg Film-Coated Tablet Vortioxetine (as hydrobromide) 20 mg Film-Coated Tablet Zonisamide 100 mg Capsule Zonisamide 50 mg Capsule Zonisamide 25 mg Capsule F. Generic Name Dosage Strength Dosage Form Isoniazid + Pyridoxine 200 mg/20 mg/5 mL Syrup (Orange Flavor) Rifampicin + Isoniazid + Pyrazinamide + Ethambutol HCl 150 mg/75 mg/400 mg/275 mg Film-Coated Tablet Rifampicin + Isoniazid 300 mg/150 mg Film-Coated Tablet Rifampicin + Isoniazid + Ethambutol + Hydrochloride 150 mg/75 mg/275 mg Film-Coated Tablet G. Generic Name Dosage Strength Dosage Form Abemaciclib 50 mg Film-Coated Tablet Abemaciclib 100 mg Film-Coated Tablet Abemaciclib 150 mg Film-Coated Tablet Abemaciclib 200 mg Film-Coated Tablet Alpelisib 200 mg Film-Coated Tablet (200 mg Daily Dose) Alpelisib 250 mg + 50 mg (250 mg daily dose) Film-Coated Tablet Alpelisib 150 mg + 150 mg (300 mg daily dose) Film-Coated Tablet Docetaxel (as trihydrate) 40 mg/mL Concentrate Solution for IV Infusion Doxorubicin Hydrochloride 2 mg/mL (50 mg/25 mL) Solution for Liposomal Injection (IV) Doxorubicin Hydrochloride 2 mg/mL (20 mg/10 mL) Solution for Liposomal Injection (IV) Doxorubicin Hydrochloride 10 mg Lyophilized Powder for Injection (IV Infusion) Enzalutamide 40 mg Capsule Epirubicin 2 mg/mL (10 mg/5 mL) Concentrate Solution for Injection (IV/Intravesical) Epirubicin Hydrochloride 2 mg/mL Concentrate Solution for Injection (IV/Intravesical) Fluorouracil 25 mg/mL (250 mg/10 mL) Solution for Injection (IV) Gefitinib 250 mg Tablet Lenalidomide 5 mg Capsule Lenalidomide 10 mg Capsule Lenalidomide 15 mg Capsule Lenalidomide 25 mg Capsule Ondansetron (as hydrochloride dihydrate) 2 mg/mL (4 mg/2 mL) Solution for Injection (I.M./I.V.) Oxaliplatin 2 mg/mL Concentrate Solution for Injection (IV Infusion) Paclitaxel 100 mg Lyophilized Powder for (I.V. Infusion) Palonosetron (as hydrochloride) 50 mcg/mL (75 mcg/1.5 mL) Solution for I.V. Injection Palonosetron (as hydrochloride) 50 mcg/mL (250 mcg/5 mL) Solution for Intravenous Injection Pazopanib (as hydrochloride) 200 mg Film-Coated Tablet Pazopanib (as hydrochloride) 400 mg Film-Coated Tablet Pemetrexed (as disodium) 1 g Lyophilized Powder for Solution for IV Infusion Tocilizumab 80 mg/4 mL (20 mg/mL) Concentrate for Solution for Infusion (IV) Tocilizumab 162 mg/0.9 mL Solution for Injection (SC) Topotecan (as hydrochloride) 1 mg/mL Concentrate Solution for IV Infusion Vinorelbine (as tartrate) 30 mg Softgel Capsule H. Generic Name Dosage Strength Dosage Form Amoxicillin (as Trihydrate) 250 mg Capsule Ampicillin (as sodium) + Sulbactam (as sodium) 1 g/500 mg Powder for Injection (I.V./I.M.) Ampicillin (as sodium) + Sulbactam (as sodium) 500 mg/250 mg Powder for Injection Ampicillin (as sodium) + Sulbactam (as sodium) 500 mg/250 mg Powder for Injection (IM/IV) Ampicillin (as sodium) + Sulbactam (as sodium) 750 mg Sterile Powder for Injection Ampicillin (as sodium) + Sulbactam (as sodium) 1.5 g (1g + 500 g) Powder for Injection (IM/IV) Ampicillin (as sodium) + Sulbactam (as sodium) 1.5 g Powder for Injection (IM/IV) Ampicillin (as sodium) + Sulbactam (as sodium) 1 g/500 g Powder for Injection (IV/IM) Atracurium (as besilate) 10 mg/mL (25 mg/2.5 mL) Solution for Injection (I.V.) Atracurium Besilate 10 mg/mL (50 mg/5 mL) Solution for Injection for I.V. Infusion Budesonide 250 mcg/mL (500 mcg/2 mL) Suspension for Nebulization Budesonide 200 mcg Pressurized Metered Dose Inhaler Budesonide 250 mcg/mL (500 mcg/mL) Suspension for Nebulization Budesonide 200 mcg Dry Powder in Capsule for Oral Inhalation Budesonide 500 mcg/mL (1000 mcg/2 mL) Nebulizing Suspension (Sterile) Budesonide 200 mcg per Actuation Metered Dose Inhaler Budesonide 250 mcg/mL Respiratory Suspension Budesonide 200 mcg Metered Dose Inhalation Budesonide 64 mcg per actuation Aqueous Nasal Spray Budesonide 200 mcg/dose Powder for Inhalation Budesonide/Formoterol Fumarate Dihydrate 80 mcg/4.5 mcg Powder for Inhalation Budesonide/Formoterol Fumarate Dihydrate 320 mcg/9 mcg per dose Powder for Inhalation Budesonide + Formoterol Fumarate Dihydrate 200 mcg/6 mcg Dry Powder for Inhalation Cefazolin (as sodium) 500 mg Powder for Injection (IV/IM) Cefepime (as hydrochloride) 1 g Powder for Injection (I.M./I.V.) Cefepime (as hydrochloride) 2 g Powder for Injection (IV/IM) Cefepime (as hydrochloride) 500 mg Powder for Injection (IV/IM) Cefotaxime (as sodium) 1 g Powder for Injection (I.M./I.V.) Cefotaxime (as sodium) 500 mg Powder for Injection (IM/IV) Cefotaxime (as sodium) 250 mg Powder for Injection (IV/IM) Cefotaxime (as sodium) 1 g Powder for Injection (IV Infusion) Ceftazidime (as pentahydrate) 1 g Powder for Injection (IV/IM) Ceftazidime (as pentahydrate) 500 mg Powder for Injection (IM/IV) Ceftazidime (as pentahydrate) 2 g Powder for I.V. Infusion Ceftriaxone (as Sodium) 1 g Powder for Injection (IM/IV) Ceftriaxone (as Sodium) 2 g Powder for Injection (IM/IV) Ceftriaxone (as sodium) + Sulbactam (as sodium) 1 g/500 mg Powder for Injection (IM/IV) Ceftriaxone (as sodium) 500 mg Powder for Injection (IM/IV) Cefuroxime (as axetil) 500 mg Film-Coated Tablet Cefuroxime (as sodium) 1.5 g Powder for Injection Cefuroxime (as sodium) 750 mg Powder for Injection (IM/IV) Cefuroxime (as axetil) 250 mg/5 mL Powder for Suspension Cefuroxime (as axetil) 125 mg/5 mL Powder for Suspension Cefuroxime (as axetil) 125 mg/5 mL Powder for Oral Suspension Cefuroxime (as axetil) 250 mg/5 mL Granules for Oral Suspension Cefuroxime Axetil 500 mg Film-Coated Tablet Ciprofloxacin (as hydrochloride) 2 mg/mL (200 mg/100 mL) Solution for Injection (IV Infusion) Ciprofloxacin (as hydrochloride) 500 mg Film-Coated Tablet Ciprofloxacin (as hydrochloride) 750 mg Film-Coated Tablet Ciprofloxacin (as hydrochloride) 2 mg/mL Solution for IV Infusion Clindamycin (as hydrochloride) 300 mg Capsule Clindamycin (as phosphate) 150 mg/mL Solution for Injection (I.M./I.V.) Clindamycin (as hydrochloride) 150 mg Capsule Dalteparin Sodium 2500 IU/0.2 mL Solution for Injection (SC) Dexamethasone 4 mg/mL (8 mg/2 mL) Solution for Injection (IM/IV) Dexamethasone Phosphate (as sodium) 4 mg/mL Solution for Injection (IV/IM) Enoxaparin sodium 60 mg/0.6 mL Solution for Injection (SC) Enoxaparin sodium 40 mg/0.4 mL Solution for Injection (SC) Enoxaparin sodium 4000 IU (40 mg)/0.4 mL Solution for Injection (IV/SC) Enoxaparin Sodium 6,000 IU (60 mg)/0.6 mL Solution for Injection (IV/SC) Enoxaparin Sodium 40 mg/0.4 mL Solution for Injection (SC) Enoxaparin Sodium 20 mg/0.2 mL Solution for Injection (IV/SC) Fentanyl (as citrate) 100 mcg (equivalent to 157.1 mcg Fentanyl citrate) Sublingual Tablet Fentanyl (as citrate) 200 mcg (equivalent to 314 mcg Fentanyl citrate) Sublingual Tablet Fentanyl (as citrate) 10 mcg/mL Solution for Injection (IV/SC) Fentanyl (as citrate) 50 mcg/mL Solution for Injection (IM/IV) Fentanyl (as citrate) 50 mcg/mL (100 mcg/2 mL) Solution for Injection (IM/IV) Fentanyl (as citrate) 100 mcg/2 mL (50 mcg/mL) Solution for Injection (IM/IV) Fondaparinux Sodium 10 mg/0.8 mL (12.5 mg/mL) Solution for Injection (SC) Fondaparinux Sodium 7.5 mg/0.6 mL (12.5 mg/mL) Solution for Injection (SC) Fondaparinux Sodium 5 mg/0.4 mL (12.5 mg/mL) Solution for Injection (SC) Heparin sodium 1000 IU/mL Solution for Injection (IV/SC) Levofloxacin 500 mg/100 mL Solution for IV Infusion Levofloxacin (as hemihydrate) 5 mg/mL Solution for IV Infusion Levofloxacin (as hemihydrate) 500 mg Film-Coated Tablet Levofloxacin (as hemihydrate) 250 mg Film-Coated Tablet Levofloxacin (as hemihydrate) 750 mg Film-Coated Tablet Levofloxacin (as hemihydrate) 5 mg/5 mL (500 mg/100 mL) Solution for intravenous infusion Levofloxacin (as hemihydrate) 5 mg/mL (500 mg/100 mL) Solution for intravenous infusion Meropenem 1 g Powder for Injection (IV) Meropenem (as trihydrate) 1 g Powder for Injection (IV) Meropenem 500 mg Sterile Powder for Injection Metronidazole 500 mg/100 mL (0.5% w/v) Solution for Injection Metronidazole (as benzoate) 125 mg/5 mL Oral Suspension Norepinephrine (as bitartrate) 1 mg/mL (4 mg/4 mL) Solution for Injection (IV) Norepinephrine (as bitartrate) 1 mg/mL Concentrate for IV Infusion Norepinephrine (as bitartrate) 1 mg/mL Solution for Injection Norepinephrine (as bitartrate) 1 mg/mL (4 mg/4 mL) Concentrate for Solution for IV Infusion Piperacillin (as sodium) + Tazobactam (as sodium) 4 g/500 mg Powder for Injection (IV) Piperacillin (as sodium) + Tazobactam (as sodium) 4 g/500 mg Powder for IV Infusion Piperacillin (as sodium) + Tazobactam (as sodium) 2 g/250 mg Powder for IV Infusion Piperacillin (as sodium) + Tazobactam (as sodium) 2 g/250 mg Powder for Injection (IV) Remdesivir 100 mg Lyophilized Powder for Injection for I.V. Infusion Rocuronium Bromide 10 mg/mL Solution for Injection (IV) Vancomycin 1 g Powder for Injection (I.V.) Vancomycin 500 mg Powder for Injection (I.V.) Vancomycin (as hydrochloride) 500 mg Powder for Injection (IV) Vancomycin (as hydrochloride) 1 g Powder for Injection (IV) Vancomycin (as hydrochloride) 500 mg Lyophilized Powder for IV Infusion Vancomycin (as hydrochloride) 1000 mg Powder for Solution for Injection (IV) Vancomycin (as hydrochloride) 500 mg Powder for Injection (IV Infusion) Vancomycin (as hydrochloride) 1 g Powder for Injection (IV Infusion) Should you have any questions/clarifications, kindly address them to the FDA Policy and Planning Service at [emailprotected]. Thank you very much. Very truly yours, (SGD.) DR. OSCAR G. GUTIERREZ, JR. Officer-in-Charge-Director General