The subsidiary of Shilpa Medicare on April 6 has received approval from the UK health regulator for anti-cancer drug Imatinib.
"The approval of Imatinib Oral Solution represents a major step forward in treatment options for cancers in paediatric and geriatric patients, patients with swallowing difficulties and also offers dose titration across the patient population," said the company in its BSE filing.
Its United Kingdom-based subsidiary Koanaa Healthcare has received approval from Medicines and Healthcare products Regulatory Authority (MHRA) for Imatinib oral solution.
"Imatinib Oral Solution, a first of its kind in the world, is the only approved product which facilitates accurate dose titrations and avoids unnecessary overdosing due to fixed doses, 100 mg and 400 mg, in the presently available marketed tablets," Shilpa Medicare said.
It said the drug was expected to be available in the UK in the second quarter of 2020 and would be supplied from its UK-based manufacturing facility LM Pharmaceuticals.
According to IQVIA MAT Q4 2019 data, the worldwide market is approximately $1.6 billion and in UK is approximately $104.4 million, it said.
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