(Reuters) -British pharmaceutical giant GSK has not met required ethical and regulatory standards in the marketing and prescription information for its Omjjara drug, an industry self-regulatory body said on Tuesday.
Omjjara is used to treat symptoms such as an enlarged spleen in adults with myelofibrosis – a rare bone marrow blood cancer – and moderate to severe anemia.
The prescribing information provided for the drug misled women using hormonal contraceptives about the necessity for extra precautions to prevent pregnancy, the Prescription Medicines Code of Practice Authority (PMCPA) said.
In response, a GSK spokesperson said: “We take adherence to industry codes and regulations very seriously.”
(Reporting by Chandini Monnappa in Bengaluru; Editing by Mrigank Dhaniwala and Nivedita Bhattacharjee)
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