Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned
subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US
Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for
Lidocaine and Prilocaine Cream USP, 2.5%/2.5%. The approved ANDA is therapeutically
equivalent to the reference listed drug product (RLD) EMLA Cream, 2.5%/2.5%, of Teva
Branded Pharmaceutical Products R&D, Inc. Lidocaine 2.5% and Prilocaine 2.5% cream (a
eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on normal intact skin for local analgesia and genital mucous membranes for
superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine 2.5% and
Prilocaine 2.5% cream is not recommended in any clinical situation when penetration or
migration beyond the tympanic membrane into the middle ear is possible because of the
ototoxic effects observed in animal studies
Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US$29
million for twelve months ending Dec. 2021 according to IQVIA.
Alembic has received a cumulative total of 163 ANDA approvals (140 final approvals and 23
tentative approvals) from USFDA.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, a vertically integrated research and development
pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered
in India, Alembic is a publicly listed company that manufactures and markets generic
pharmaceutical products all over the world. Alembic’s state of the art research and
manufacturing facilities are approved by regulatory authorities of many developed countries
including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s
brands, marketed through a marketing team of over 5000 are well recognized by doctors and
patients.
Information about Alembic can be found at https://www.alembicpharmaceuticals.com/;
