Lupin Limited, a global pharmaceutical major, has seen its share price reach a 52-week high following the launch of its generic Mirabegron Extended-Release Tablets, 50 mg, in the United States. The approval from the United States Food and Drug Administration (USFDA) has enabled Lupin to introduce a generic equivalent of Myrbetriq Extended-Release Tablets, developed by […]
Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has achieved a significant regulatory milestone by receiving final approval from the United States Food and Drug Administration (USFDA) for Amantadine extended-release capsules, 68.5 mg. The company has also secured tentative approval for the 137 mg dosage. The drug, which will be marketed under the brand […]
Alembic Pharmaceuticals Limited has achieved a significant milestone by securing tentative approval from the US Food & Drug Administration (USFDA) for its Selexipag for Injection, 1,800 mcg/vial. This approval, a critical step in the generic drug application process, marks Alembic’s potential entry into the U.S. market with a generic version of Uptravi for Injection, originally […]
Zydus Lifesciences Limited has achieved a significant milestone with the tentative approval from the United States Food and Drug Administration (USFDA) to market Azilsartan Medoxomil Tablets, in 40 mg and 80 mg dosages. This medication is an angiotensin II receptor blocker (ARB) specifically used for the treatment of hypertension to lower blood pressure, thereby reducing […]
Alembic Pharmaceuticals Limited has achieved a significant milestone with the US Food & Drug Administration’s (USFDA) final approval of its Abbreviated New Drug Application (ANDA) for Icatibant Injection, used in the treatment of acute attacks of hereditary angioedema (HAE) in adults. This approval marks the first peptide product approval for Alembic, showcasing their commitment to […]
Gland Pharma Limited, a prominent player in the generic injectable-focused pharmaceutical industry, has received approval from the United States Food and Drug Administration (USFDA) for its Edaravone Injection. This approval marks a significant milestone for the company as it prepares to offer new therapeutic options for patients suffering from amyotrophic lateral sclerosis (ALS). Product Details […]
Zydus Lifesciences Limited has announced the launch of Mirabegron Extended-Release Tablets, 25 mg, in the US market, following the final approval from the United States Food and Drug Administration (USFDA). This introduction marks Zydus as one of the first suppliers to offer the generic version of this medication, which is primarily used for the treatment […]
Strides Pharma Science Limited (Strides) has made a notable advancement in the field of mental health treatment by securing approval from the United States Food & Drug Administration (USFDA) for its Fluoxetine Tablets 10 mg and 20 mg. This development is significant for Strides’ subsidiary, Strides Pharma Global Pte. Limited, Singapore, positioning the company as […]
In a significant advancement for generic pharmaceuticals, Gland Pharma Limited, a company specializing in generic injectable-focused pharmaceutical products, has announced receiving approval from the United States Food and Drug Administration (USFDA) for its Eribulin Mesylate Injection, 0.5 mg/mL Single Dose Vial. This approval marks a crucial step forward in the availability of generic cancer treatments, […]
In a significant development for patients undergoing bone marrow or kidney transplants, Zydus Lifesciences Limited has been granted tentative approval by the United States Food and Drug Administration (USFDA) for its Letermovir tablets in 240 mg and 480 mg formulations. This approval marks a crucial step in preventing disease caused by cytomegalovirus (CMV) in these […]