Alembic Pharma JV Aleor Derma secures USFDA approval for Metronidazole Gel
Vadodara: Alembic Pharmaceuticals Limited today announced that the company's joint venture Aleor Dermaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Metronidazole Gel USP, 1 %.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Metrogel Gel, 1 %, of Galderma Laboratories LP. Metronidazole Gel USP, 1 % is indicated for the topical treatment of inflammatory lesions of rosacea.
Aleor had previously received tentative approval for this ANDA.
Metronidazole Gel USP, 1 % has an estimated market size of US$ 29 million for twelve months ending June 2021 according to IQVIA. Alembic has a cumulative total of 149 ANDA approvals (132 final approvals and 17 tentative approvals) from USFDA.
Read also: Alembic Pharma bags USFDA nod for Clomipramine Hydrochloride Capsules to treat OCD
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.