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.
Caplin Steriles gets USFDA approval for Argatroban Injection
Posted On: 2021-01-22 01:05:29 (Time Zone: Arizona, USA)
Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT) 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