UK Drugs Regulator Halts Approvals for Quest Life Sciences
The UK's healthcare regulator has suspended marketing approval for a widely used antibiotic that had won clearance based on clinical trials conducted by India's Quest Life Sciences, due to concerns over the integrity of trial data.
The Medicines and Healthcare products Regulatory Agency (MHRA) might also deny other pending drug approval requests that rely on studies conducted by Quest, the UK agency said in a letter dated June 22, a copy of which was seen by Reuters.
The MHRA's decision bars the sale of a generic version of erythromycin that is being sold in the UK by Dawa Ltd, a Kenyan drugmaker, an MHRA spokesman said.
The Medicines and Healthcare products Regulatory Agency (MHRA) might also deny other pending drug approval requests that rely on studies conducted by Quest, the UK agency said in a letter dated June 22, a copy of which was seen by Reuters.
The MHRA's decision bars the sale of a generic version of erythromycin that is being sold in the UK by Dawa Ltd, a Kenyan drugmaker, an MHRA spokesman said.