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The four drugs recently launched include a generic of Clindagel, which received a competitive generic therapy designation from the FDA, for acne and Vasostrict for low blood pressure.
The FDA has approved four of Amneal’s abbreviated new drug applications. The first clindamycin phosphate topical gel, a generic version of Ortho Dermatologic’s Clindagel to treat patients with acne. This product received competitive generic therapy (CGT) approval designation, a designation the FDA provides for areas where there is inadequate generic competition. It provides a 180-day exclusivity period to the generic company.
The second is vasopressin injection 1mL (single-dose), a generic version of the antidiuretic hormone Par’s Vasostrict. It is used to increase blood pressure in patients who remain hypotensive after fluids. Company leaders said in a press release that vasopressin product expands its injectables portfolio and drives further scale in that business for Amneal.
The third approval is famotidine for oral suspension, an H2 antagonist, is a generic equivalent for Johnson & Johnson’s Pepcid, which is used to treat ulcers and dastroesophageal reflux disease. The final approval is atropine sulfate 1% ophthalmic solution, an anticholinergic, which is used to treat cycloplegia (paralysis of the ciliary muscle of the eye), amblyopia (lazy eye) and dilated pupils.
Each year, Ammeal aims to launch 20 to 30 new generic product, and company leaders say they are on track to achieving that goal again in 2022.
Other recently approved generics include: