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Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Daptomycin Brand(s): Cubicin RF and generic daptomycin (Refer to the formulary for funded list) DOSAGE FORM/ STRENGTH: 500 mg/10 mL powder for injection Note that initial requests for Daptomycin may be accessed through the EAP’s Telephone Request Service for some of the below indications (see latter part of this document under TRS). For the treatment of patients experiencing the following types of infections due to methicillin-resistant Staphylococcus aureus (MRSA) bacteria; i) Staphylococcus aureus bloodstream (SAB) infection including right-sided Staphylococcus aureus infective endocarditis (SARIE); AND/OR ii) Osteomyelitis; AND/OR iii) Device-related osteoarticular or prosthetic joint infections; AND/OR iv) Diabetic foot infections. Additionally, the patient must have failed to adequately respond to, be intolerant1 to, or have a contraindication to vancomycin. 1Intolerance due to Red Man Syndrome. If the physician asserts that the patient is intolerant to vancomycin due to red man’s syndrome, additional clinical details of the patient’s intolerance, including rate of infusion and the use of antihistamines and other histamine blockers prior to therapy with vancomycin. Duration of Approval: Up to 8 weeks Renewals will be considered on a case-by-case basis. (Physicians must submit adequate clinical information to justify the need for ongoing therapy with daptomycin.) Duration of Approval: Case-by-case Exclusion Criteria: • Daptomycin is not funded for patients with MRSA-related pneumonia; • Daptomycin is not funded for patients with skin/skin structure infections other than diabetic foot infections caused by MRSA. 41 Daptomycin Brand(s): Cubicin RF, generic daptomycin products (refer to the formulary list) DOSAGE FORM/ STRENGTH: 500 mg/10 mL powder for injection For the treatment of invasive infections1 caused by vancomycin-resistant enterococcus (VRE) in patients who meet the following criteria: 1. VRE infection is confirmed by blood or tissue culture and sensitivity report 2. Patient is unable to use linezolid as a result of at least ONE of the following reasons: i) has developed resistance to linezolid as confirmed by the microbiology sensitivity report ii) has experienced intolerance2 to linezolid (for example: severe gastric symptoms, myelosuppression, peripheral neuropathy requiring medical intervention, lactic acidosis) iii) has a contraindication2 to linezolid OR Prescribed by an infectious disease expert for a patient who is able to use linezolid but where the bacteriostatic effect of linezolid may not be deemed to be clinically optimal due to other patient factors or comorbidities (e.g., immunocompromised, neutropenic). 1Not approved for colonization (e.g., nares, skin, stool) 2Intolerances and contraindications to linezolid must be fully described in the EAP application. Recommended dose: 8 to 12 mg/kg daily for VRE with adjustments based on renal function Duration of approval: Note that the below are examples of durations for reimbursement of some common VRE infections. This is not an all-inclusive list. Urinary tract infections: up to 10 days Bacteremia: up to 14 days Endocarditis: up to 6 weeks Osteomyelitis: up to 8 weeks Requests for longer durations of funding will be considered case-by-case through external review and must be accompanied by a recent microbiology sensitivity report to confirm sensitivity to daptomycin. 42  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 41, record 21, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Daptomycin Brand(s): Cubicin RF, daptomycin generics (refer to formulary for funded drugs) DOSAGE FORM/ STRENGTH: 500 mg/10mL injection Effective date: October 11, 2011 Updated October 21, 2014; July 30, 2021 (VRE) For the treatment of patients with one or more of the following condition(s): 1. Osteomyelitis caused by methicillin-resistant staphylococcus aureus (MRSA) 2. Device-related osteoarticular or prosthetic joint infections caused by methicillin resistant staphylococcus aureus (MRSA); 3. Diabetic foot infections caused by methicillin-resistant staphylococcus aureus (MRSA);AND/OR 4. Staphyloccoccus aureus bloodstream (SAB) infection including right-sided Staphylococcus aureus infective endocarditis (SARIE) infection caused by methicillin- resistant Staphylococcus aureus (MRSA) Additionally, the patient must have failed to adequately respond to, be intolerant* to, or have a contraindication to vancomycin. *Requests involving red-man-syndrome with vancomycin must provide details of the intolerance including the rate of infusion and the use of antihistamines and other histamine blockers prior to therapy. Standard Approval Duration: Up to maximum of 56 days Exclusion Criteria: Daptomycin is not funded for patients with: a) MRSA-related pneumonia; b) skin/skin structure infections other than diabetic foot infections caused by MRSA. 462 Daptomycin Brand(s): Cubicin RF, generic daptomycin (refer to the formulary for funded list) DOSAGE FORM/ STRENGTH: 500 mg/10 mL powder for injection For the treatment of invasive infections1 caused by vancomycin-resistant enterococcus (VRE) in patients who meet the following criteria: 1. VRE infection is confirmed by blood or tissue culture and sensitivity report 2. Patient is unable to use linezolid as a result of at least ONE of the following reasons: i) has developed resistance to linezolid as confirmed by the microbiology sensitivity report ii) has experienced intolerance2 to linezolid (for example: severe gastric symptoms, myelosuppression, peripheral neuropathy requiring medical intervention, lactic acidosis) iii) has a contraindication2 to linezolid OR Prescribed by an infectious disease expert for a patient who is able to use linezolid but where the bacteriostatic effect of linezolid may not be deemed to be clinically optimal due to other patient factors or comorbidities (e.g., immunocompromised, neutropenic). 1 Not approved for colonization (e.g., nares, skin, stool) 2 Intolerances and contraindications to linezolid must be fully described in the EAP application. Recommended dose: 8 to 12 mg/kg daily for VRE with adjustments based on renal function Duration of approval: Note that the below are examples of durations for reimbursement of some common VRE infections. This is not an all-inclusive list. Urinary tract infections: up to 10 days Bacteremia: up to 14 days Endocarditis: up to 6 weeks Osteomyelitis: up to 8 weeks Requests for longer durations of funding will be considered case-by-case through external review and must be accompanied by a recent microbiology sensitivity report to confirm sensitivity to daptomycin. 463  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 462, record 298, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Daptomycin for Injection · DIN 02490463 Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2020-11-30 Health Canada: Marketed since 2020-11-19 · brand DAPTOMYCIN FOR INJECTION · ATC J01XX09 DAPTOMYCIN · form Powder for solution · route Intravenous · ingredients DAPTOMYCIN 500 MG/VIAL · company Dr reddy's laboratories ltd · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02490463). DIN 02490463: Daptomycin for Injection Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 081228125; group id 48; item number 0105; lccId None; manufacturer id DRR Source form: Pd for Inj Sol-Vial Pk; strength: 500mg/Vial Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $162.3500; ministry $162.3500 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02490463 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98052

Interchangeable products

Cubicin · DIN 02299909 · not recorded Daptomycin for Injection · DIN 02490838 · $162.3500 Daptomycin for Injection · DIN 02511738 · $162.3500

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02490463

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Daptomycin Brand(s): Cubicin RF and generic daptomycin (Refer to the formulary for funded list) DOSAGE FORM/ STRENGTH: 500 mg/10 mL powder for injection Note that initial requests for Daptomycin may be accessed through the EAP’s Telephone Request Service for some of the below indications (see latter part of this document under TRS). For the treatment of patients experiencing the following types of infections due to methicillin-resistant Staphylococcus aureus (MRSA) bacteria; i) Staphylococcus aureus bloodstream (SAB) infection including right-sided Staphylococcus aureus infective endocarditis (SARIE); AND/OR ii) Osteomyelitis; AND/OR iii) Device-related osteoarticular or prosthetic joint infections; AND/OR iv) Diabetic foot infections. Additionally, the patient must have failed to adequately respond to, be intolerant1 to, or have a contraindication to vancomycin. 1Intolerance due to Red Man Syndrome. If the physician asserts that the patient is intolerant to vancomycin due to red man’s syndrome, additional clinical details of the patient’s intolerance, including rate of infusion and the use of antihistamines and other histamine blockers prior to therapy with vancomycin. Duration of Approval: Up to 8 weeks Renewals will be considered on a case-by-case basis. (Physicians must submit adequate clinical information to justify the need for ongoing therapy with daptomycin.) Duration of Approval: Case-by-case Exclusion Criteria: • Daptomycin is not funded for patients with MRSA-related pneumonia; • Daptomycin is not funded for patients with skin/skin structure infections other than diabetic foot infections caused by MRSA. 41 Daptomycin Brand(s): Cubicin RF, generic daptomycin products (refer to the formulary list) DOSAGE FORM/ STRENGTH: 500 mg/10 mL powder for injection For the treatment of invasive infections1 caused by vancomycin-resistant enterococcus (VRE) in patients who meet the following criteria: 1. VRE infection is confirmed by blood or tissue culture and sensitivity report 2. Patient is unable to use linezolid as a result of at least ONE of the following reasons: i) has developed resistance to linezolid as confirmed by the microbiology sensitivity report ii) has experienced intolerance2 to linezolid (for example: severe gastric symptoms, myelosuppression, peripheral neuropathy requiring medical intervention, lactic acidosis) iii) has a contraindication2 to linezolid OR Prescribed by an infectious disease expert for a patient who is able to use linezolid but where the bacteriostatic effect of linezolid may not be deemed to be clinically optimal due to other patient factors or comorbidities (e.g., immunocompromised, neutropenic). 1Not approved for colonization (e.g., nares, skin, stool) 2Intolerances and contraindications to linezolid must be fully described in the EAP application. Recommended dose: 8 to 12 mg/kg daily for VRE with adjustments based on renal function Duration of approval: Note that the below are examples of durations for reimbursement of some common VRE infections. This is not an all-inclusive list. Urinary tract infections: up to 10 days Bacteremia: up to 14 days Endocarditis: up to 6 weeks Osteomyelitis: up to 8 weeks Requests for longer durations of funding will be considered case-by-case through external review and must be accompanied by a recent microbiology sensitivity report to confirm sensitivity to daptomycin. 42  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 41, record 21, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Daptomycin Brand(s): Cubicin RF, daptomycin generics (refer to formulary for funded drugs) DOSAGE FORM/ STRENGTH: 500 mg/10mL injection Effective date: October 11, 2011 Updated October 21, 2014; July 30, 2021 (VRE) For the treatment of patients with one or more of the following condition(s): 1. Osteomyelitis caused by methicillin-resistant staphylococcus aureus (MRSA) 2. Device-related osteoarticular or prosthetic joint infections caused by methicillin resistant staphylococcus aureus (MRSA); 3. Diabetic foot infections caused by methicillin-resistant staphylococcus aureus (MRSA);AND/OR 4. Staphyloccoccus aureus bloodstream (SAB) infection including right-sided Staphylococcus aureus infective endocarditis (SARIE) infection caused by methicillin- resistant Staphylococcus aureus (MRSA) Additionally, the patient must have failed to adequately respond to, be intolerant* to, or have a contraindication to vancomycin. *Requests involving red-man-syndrome with vancomycin must provide details of the intolerance including the rate of infusion and the use of antihistamines and other histamine blockers prior to therapy. Standard Approval Duration: Up to maximum of 56 days Exclusion Criteria: Daptomycin is not funded for patients with: a) MRSA-related pneumonia; b) skin/skin structure infections other than diabetic foot infections caused by MRSA. 462 Daptomycin Brand(s): Cubicin RF, generic daptomycin (refer to the formulary for funded list) DOSAGE FORM/ STRENGTH: 500 mg/10 mL powder for injection For the treatment of invasive infections1 caused by vancomycin-resistant enterococcus (VRE) in patients who meet the following criteria: 1. VRE infection is confirmed by blood or tissue culture and sensitivity report 2. Patient is unable to use linezolid as a result of at least ONE of the following reasons: i) has developed resistance to linezolid as confirmed by the microbiology sensitivity report ii) has experienced intolerance2 to linezolid (for example: severe gastric symptoms, myelosuppression, peripheral neuropathy requiring medical intervention, lactic acidosis) iii) has a contraindication2 to linezolid OR Prescribed by an infectious disease expert for a patient who is able to use linezolid but where the bacteriostatic effect of linezolid may not be deemed to be clinically optimal due to other patient factors or comorbidities (e.g., immunocompromised, neutropenic). 1 Not approved for colonization (e.g., nares, skin, stool) 2 Intolerances and contraindications to linezolid must be fully described in the EAP application. Recommended dose: 8 to 12 mg/kg daily for VRE with adjustments based on renal function Duration of approval: Note that the below are examples of durations for reimbursement of some common VRE infections. This is not an all-inclusive list. Urinary tract infections: up to 10 days Bacteremia: up to 14 days Endocarditis: up to 6 weeks Osteomyelitis: up to 8 weeks Requests for longer durations of funding will be considered case-by-case through external review and must be accompanied by a recent microbiology sensitivity report to confirm sensitivity to daptomycin. 463  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 462, record 298, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Daptomycin for Injection · DIN 02490838 Manufacturer: Sandoz Canada Inc.; listing date 2020-11-30 Health Canada: Marketed since 2020-10-27 · brand DAPTOMYCIN FOR INJECTION · ATC J01XX09 DAPTOMYCIN · form Powder for solution · route Intravenous · ingredients DAPTOMYCIN 500 MG/VIAL · company Sandoz canada incorporated · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02490838). DIN 02490838: Daptomycin for Injection Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 081228125; group id 48; item number 0105; lccId None; manufacturer id SDZ Source form: Pd for Inj Sol-Vial Pk; strength: 500mg/Vial Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $162.3500; ministry $162.3500 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02490838 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98087

Interchangeable products

Cubicin · DIN 02299909 · not recorded Daptomycin for Injection · DIN 02490463 · $162.3500 Daptomycin for Injection · DIN 02511738 · $162.3500

Shortage status: resolved shortage (ended 2026-03-23); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02490838

Shortage record checked 2026-09-13T08:10:21.292534+00:00