New Delhi, Oct 22 (PTI) Drug firm Alembic Pharmaceuticals on Thursday said its joint venture firm Aleor Dermaceuticals has received final approval from the US health regulator for anti-fungal Tavaborole Topical Solution.

Tavaborole Topical solution is an antifungal indicated for the treatment of onychomycosis of the toenails.

Also Read | Jeff Goldblum Birthday: 7 Golden Movie Quotes of the Actor That Almost Seem Improvised.

Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tavaborole Topical Solution, 5 per cent, Alembic Pharmaceuticals said in a BSE filing.

Aleor had previously received tentative approval for this ANDA. 

Also Read | Truecaller Introduces 'Call Reason', 'Schedule SMS' & 'SMS Translate' Features for Users: Report.

"Aleor was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared exclusivity," the company added.

Quoting IQVIA data, Alembic Pharma said Tavaborole Topical Solution, 5 per cent, had an estimated market size of USD 82 million for twelve months ending June 2020.

Alembic Pharma has a cumulative total of 133 ANDA approvals (116 final approvals and 17 tentative approvals) from the USFDA.

Shares of Alembic Pharmaceuticals were trading 0.35 per cent lower at Rs 993.60 apiece on BSE.

(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)