Caplin Steriles receives final USFDA approval for Argatroban Injection

Caplin Point Laboratories announced that its subsidiary, Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Argatroban Injection, 50 mg/50 ml (1 mg/ml) Single-dose vial presentation, a generic therapeutic equivalent version of (RLD), ARGATROBAN INJECTION, of Hikma Pharmaceuticals.

Caplin has received a CGT (Competitive Generic Therapies) Grant for this ANDA and Caplin is the "first approved applicant" for such competitive generic therapy, as defined in section 505(j)(5)(B)(v)(III) of the FD&C Act. Therefore, with this approval, Caplin is eligible for 180 days of CGT exclusivity for Argatroban Injection, 50 mg/50 ml (1 mg/ml) Single- Dose Vial, under section 505(j)(5)(B)(v) of the FD&C Act.

Argatroban is used as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia. According to IQVIA {IMS Health), Argatroban Injection had US sales data of approximately $18 million for the 12-month period ending September 2020.

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