Cosette Pharmaceuticals and Alembic Pharmaceuticals Limited Announce the Approval and Launch of a National Brand Equivalent (NBE) of Abreva® (Docosanol Cream 10%) Including the First Approval in the Pump Format

May 24, 2022 |

2 min read

Cosette Pharmaceuticals, Inc (“Cosette”), in collaboration with Aleor Dermaceuticals, a wholly owned subsidiary of Alembic Pharmaceuticals (“Alembic”; BSE: 533573), announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for an NBE version of Abreva® (Docosanol cream 10%) in a 2 gm tube and pump formats.

May 24, 2022 11:00 UTC

BRIDGEWATER, N.J. & VADODARA, India--(BUSINESS WIRE)-- Cosette Pharmaceuticals, Inc (“Cosette”), in collaboration with Aleor Dermaceuticals, a wholly owned subsidiary of Alembic Pharmaceuticals Limited (“Alembic”; BSE: 533573), announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for an NBE version of Abreva® (Docosanol cream 10%) in a 2 gm tube and pump formats. Shipments of the product will begin imminently.

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Abreva (Photo: Business Wire)

Apurva Saraf, CEO of Cosette Pharma and Pranav Amin, MD of Alembic Pharma stated, “This approval and launch highlights our ability to successfully partner and bring important complex products to market. We look forward to launching this Private Label, Over-the-Counter product with our retail partners in the US.”

This approval represents the first ANDA approval in the pump format and Cosette plans to launch the product across the US retail channel.

* Abreva® is a licensed trademark of GlaxoSmithKline

About Cosette Pharmaceuticals, Inc.:

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. The current products focus on complex dosage forms including topical creams, ointments, oral liquids/solutions, suppositories, and injectables. Cosette has a long history of quality manufacturing, consistent supply, and commercialization success, including two sites (New Jersey and North Carolina) supported by more than 350+ dedicated employees across all functional areas. Cosette is backed by Avista Capital Partners, a healthcare focused private equity firm. www.cosettepharma.com

About Alembic Pharmaceuticals, Inc.:

Alembic Pharmaceuticals, Inc. is a vertically integrated research and development pharmaceutical company, and 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 5,000 are well recognized by doctors and patients. Information about Alembic can be found at http://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLL TD) (BSE: 533573)