Drug Approval | April 24, 2025
Caplin Steriles gets USFDA approval for Phytonadione Injectable Emulsion
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia
According to IQVIATM sales data for the 12-month period ending February 2025, the Adderall Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market3 achieved annual sales of approximately $421.7 million.
Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA
The product will be launched in Q1FY26
The company expects to launch this product through its marketing partner in the near future
Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of US$ 48 million for twelve months ending December 2024 according to IQVIA
According to IQVIA sales data for the 12-month period ending January 2025, the Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial and 1.5 g/vial (Single-dose vial) market achieved annual sales of approximately $39.3 mn
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure
This launch of Epinephrine Injection multiple-dose Vial is eligible for 180 days of CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.
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