Caplin Steriles gets USFDA nod for generic Argatroban injection

Argatroban is used as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia.

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Medicine Injection drug vaccine Syringe
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Last Updated on January 23, 2021 by The Health Master

Caplin Steriles Limited (Caplin), a subsidiary company of Caplin Point Laboratories Limited, 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 Limited.

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.


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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 of approximately US$ 18 million for the 12-month period ending September 2020.

C C Paarthipan, chairman of Caplin Point Laboratories Limited commented, “We’re excited to receive our first approval with CGT exclusivity from our pipeline. We will target launching the product within the shortest time possible.”


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