Glenmark Generics Incorporation, USA, a subsidiary of Glenmark Generics, has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (USFDA) for Imiquimod Cream 5%, their generic version of Aldara by Medicis Pharmaceutical Corporation and has commenced shipping immediately upon approval.
Imiquimod Cream 5% is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults and for the treatment of external genital and perianal warts/condyloma acuminate in patients 12 years old or older. According to IMS Health sales data for the 12 month period ending December 2011, Imiquimod Cream garnered annual sales of approximately $244 million.
Glenmark's current portfolio consists of 77 products authorized for distribution in the US marketplace and 40 ANDA's pending approval with the USFDA.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1847.30 |
| Dr. Reddys Lab | 1293.25 |
| Cipla | 1347.70 |
| Zydus Lifesciences | 938.90 |
| Lupin | 2377.90 |
| View more.. | |
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