Alembic Pharmaceuticals Limited has announced the receipt of final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Valganciclovir for Oral Solution, 50 mg/mL. This approval signifies the product’s therapeutic equivalence to the reference listed drug, Valcyte. The drug is indicated for treating cytomegalovirus (CMV) retinitis in AIDS patients and preventing CMV disease in transplant recipients. Alembic has now accumulated a total of 247 ANDA approvals from the USFDA.
USFDA Final Approval Secured
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Valganciclovir for Oral Solution, 50 mg/mL. This regulatory milestone allows Alembic to market the generic version of the drug in the United States.
Product Indication and Equivalence
The approved ANDA confirms that Valganciclovir for Oral Solution, 50 mg/mL is therapeutically equivalent to the reference listed drug, Valcyte for Oral Solution 50 mg/mL, manufactured by CHEPLAPHARM Arzneimittel GmbH. The medication is prescribed for two primary uses: 1) treatment of cytomegalovirus (CMV) retinitis in patients diagnosed with acquired immunodeficiency syndrome (AIDS), and 2) prevention of CMV disease in individuals who have undergone kidney, heart, or kidney-pancreas transplants and are at high risk.
Company’s USFDA Approval Pipeline
With this latest approval, Alembic Pharmaceuticals Limited now boasts a cumulative total of 247 ANDA approvals from the USFDA. This includes 227 final approvals and 20 tentative approvals, underscoring the company’s consistent success in gaining regulatory clearance for its pharmaceutical products in the key US market.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company with a rich history dating back to 1907. Headquartered in India, Alembic is publicly listed and manufactures and markets a wide array of generic pharmaceutical products globally. Its state-of-the-art research and manufacturing facilities are recognized and approved by regulatory authorities in numerous developed countries, including the USFDA. Alembic is also acknowledged as a leader in branded generics within India, with its brands widely utilized by healthcare professionals and patients.
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