TAG 2010 Pipeline Report
TABLE 3. Antiretroviral Formulations Suitable for Pediatric Use with Tentative Approval from the FDA and/or Pre-qualified by the WHO Drug
Formulation and strength
Supplier/applicant
Abacavir
Oral solution 20mg/ml
GlaxoSmithKline
•
Abacavir sulfate
Oral solution 20mg/ml
Cipla
•
Abacavir sulfate
Tablet 60mg
Aurobindo Pharma
•
Abacavir sulfate
Oral solution 20mg/ml
Aurobindo Pharma
•
Abacavir sulfate + lamivudine
Tablet 60mg/30mg
Aurobindo Pharma
•
Abacavir sulfate
Tablet 60mg
Matrix Laboratories
•
Abacavir sulfate + Lamivudine Tablet 60mg/30mg
Matrix Laboratories
•
Abacavir sulfate + lamivudine + zidovudine
Tablet 60mg/30mg/60mg
Matrix Laboratories
•
Didanosine
Powder for oral solution 2g
Bristol-Meyers Squibb
•
Didanosine
Tablets 25mg, 50mg, and 100mg
Bristol-Meyers Squibb
Didanosine
Delayed release capsules 125mg, 200mg, 250mg, and 400mg
Matrix Laboratories
•
Didanosine
Delayed release capsules 125mg, 200mg, 250mg, and 400mg
Aurobindo Pharma
•
Didanosine
Oral solution10mg/ml
Aurobindo Pharma
•
Efavirenz
Oral solution 30mg/ml
Merck Sharp & Dohme
•
Efavirenz
Capsules 50mg. and 200mg
Merck Sharp & Dohme
•
Efavirenz
Tablets 50mg, and 200mg
Merck Sharp & Dohme
•
Efavirenz
Capsule 200mg
Ranbaxy
Efavirenz
Tablet 200mg
Strides Arcolab
•
Efavirenz
Tablets 50mg, 100mg, and 200mg
Matrix Laboratories
•
Efavirenz
Capsule 200mg
Cipla
•
Efavirenz
Tablet 100mg
Aurobindo Pharma
•
Efavirenz
Capsules 50mg, 100mg, and 200mg
Aurobindo Pharma
•
Lamivudine
Oral solution 10mg/ml
GlaxoSmithKline
Lamivudine
Oral solution 10mg/ml
Cipla
•
Lamivudine
Oral solution 10mg/ml
Aurobindo
•
Lamivudine + stavudine
Tablets for oral suspension 60mg/12mg and 30mg/6mg
Cipla
•
Lamivudine + stavudine + nevirapine
Dispersible tablets 30mg/6mg/50mg and 60mg/12mg/100mg
Cipla
•
34
FDA TA WHO PQ
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