Amneal Launches Four Generics Products

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:

• Glenmark Pharmaceuticals’ generic of Allergan’s birth control Taytulla. Glenmark’s norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules is available in the same 1 mg/20 mcg strength as Taytulla.
• Cabazitaxel intravenous powder, the generic equivalent of Sanofi-Genzyme’s Jevtana Kit to treat adults with advanced prostate cancer. The generic product was developed in a collaboration between Breckenridge Pharmaceutical and Natco Pharma. The approval was granted for the 60mg/1.5mL (40mg/mL) strength.