DCGI shows green flag to Mylan TB drug Pretomanid
The Drug Controller General of India (DCGI) has approved Pretomanid for conditional access under the National Tuberculosis Elimination Program(NTEP), Mylan said in a statement.
New Delhi: Drug firm Mylan on Wednesday said it has received approval from the Indian drug regulator for anti-tuberculosis drug Pretomanid, developed specifically for drug-resistant forms of the disease.
The Drug Controller General of India (DCGI) has approved Pretomanid for conditional access under the National Tuberculosis Elimination Program (NTEP), Mylan said in a statement.
Through the conditional access approval from DCGI, Mylan will initially make its Pretomanid available in India through a donation of 400 treatment courses to the NTEP, it added.
The company also will provide commercial access to NTEP at the previously announced global access price of USD 364 for a six-month treatment course, and will be manufacturing its Pretomanid product both for domestic and global supply in India, it added.
"Mylan offers one of the world''s leading infectious disease portfolios and the approval of Pretomanid in India further supports our global commitment to transform the TB treatment landscape through greater access and affordability," Mylan President Rajiv Malik said.
To date, Mylan and TB Alliance have secured approvals for Pretomanid in two countries, he added.
"TB Alliance is committed to developing and introducing new treatments for patients with TB, including highly drug-resistant forms of this deadly disease. The approval of Pretomanid in India as part of this three-drug, all-oral regimen is the first in a country with a high TB burden," TB Alliance President and CEO Mel Spigelman said.
By embracing innovation, India has an opportunity to lead the charge to end TB and meet its ambitious goals for eradication, he added.
TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB.