Alembic Pharmaceuticals’ Joint Venture (JV) — Aleor Dermaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lidocaine Ointment USP, 5%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xylocaine Ointment, 5%, of AstraZeneca Pharmaceuticals LP (AstraZeneca). Lidocaine Ointment USP, 5% are indicated for production of anesthesia of accessible mucous membranes of the oropharynx. Lidocaine Ointment USP, 5%, has an estimated market size of $ 97 million for twelve months ending December 2017 according to IQVIA.
The company has a cumulative total of 79 ANDA approvals (66 final approvals and 13 tentative approvals) from USFDA, including this first ANDA approval for Aleor.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.