Brings year-to-date generics launches to 16; on-track for 20-30 this year
BRIDGEWATER, N.J. – Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (“FDA”) for four generics products, including vasopressin injection 1mL (single-dose).
The four recently approved products include:
Chirag and Chintu Patel, Co-Chief Executive Officers, stated, “We are pleased to add these four new products to our essential medicines portfolio. Most notably, Vasopressin expands our injectables portfolio and drives further scale in that business for us. Each year, we target 20 to 30 new product launches in generics, and we are on-track to achieving that goal again in 2022.”
Vasopressin injection 1mL is a generic version of the antidiuretic hormone Vasostrict®. For full prescribing information, see package insert located here.
Famotidine for oral suspension (40 mg/5 mL), an H2 antagonist, is a generic equivalent for Pepcid®. For full prescribing information, see package insert located here.
Atropine sulfate 1% ophthalmic solution, an anticholinergic, is a generic version of Atropine Sulfate Ophthalmic Solution, USP 1% (2 mL, 5 mL and 15 mL). For full prescribing information, see package insert located here.
Clindamycin phosphate topical gel USP, 1% (75 mL) is a generic version of Clindagel®. This product received Competitive Generic Therapy (CGT) approval designation as Amneal continues to have the highest number of CGT designated products in the industry. For full prescribing information, see package insert located here.
