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Alembic Pharmaceuticals gets USFDA nod for generic acne treatment gel
Alembic Pharmaceuticals has secured final USFDA approval for its generic Dapsone gel, a topical treatment for acne vulgaris. This approval, for the 5% strength, means the company can now market its version, which is therapeutically equivalent to Almirall's Aczone Gel. This development marks a significant step for Alembic in the US market, offering a new option for acne sufferers.
Alembic Pharma rises after receiving USFDA approval for Dapsone Gel, 5%
Alembic Pharmaceuticals rose 1.89% to Rs 786.05 after the company said that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dapsone Gel, 5%.
Alembic Pharmaceuticals receives USFDA final approval for Dapsone Gel
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapsone Gel, 5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Aczone Gel, 5%, of Almirall, LLC.
Alembic Pharma gets USFDA nod for generic influenza treatment drug
Alembic Pharmaceuticals has secured USFDA approval for its generic oseltamivir phosphate oral suspension, a key treatment for influenza. This development offers a more accessible option for patients aged two weeks and above suffering from acute, uncomplicated flu. The approval marks a significant step in providing affordable alternatives to the reference drug, Tamiflu, potentially impacting a market valued at an estimated USD 27 million.
Alembic Pharma gets USFDA nod for generic Tamiflu oral suspension
Alembic Pharmaceuticals' cumulative USFDA approvals now stand at 243 ANDAs, comprising 223 final approvals and 20 tentative approvals.
Alembic Pharma gets tentative nod from USFDA for generic cancer drug
Alembic Pharmaceuticals has secured tentative approval from the USFDA for its generic Binimetinib tablets. This marks a significant step for the company in the cancer treatment drug market. The approval is for the 45mg strength, with potential for marketing exclusivity. Alembic previously received tentative approval for the 15mg strength. Binimetinib is used in combination therapies for melanoma and lung cancer.
Alembic Pharmaceuticals receives USFDA approval for Binimetinib Tablets, 45 mg
Alembic Pharmaceuticals (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Binimetinib Tablets, 45 mg. Alembic had previously received tentative approval for Binimetinib Tablets, 15mg.
Alembic Pharma gains after receiving USFDA tentative approval for Binimetinib tablets
Alembic Pharmaceuticals advanced 1.90% to Rs 764 after the company announced that it has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg.
Alembic Pharmaceuticals receives USFDA approval for Tretinoin Cream USP, 0.05%
Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.05%, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.
Alembic Pharma gains after receiving USFDA nod for Tretinoin Cream
Alembic Pharmaceuticals rose 1.33% to Rs 744.75 after the company announced that it had received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.05%.
Alembic Pharma gains after receiving USFDA nod for Larotrectinib Capsules
Alembic Pharmaceuticals advanced 1.15% to Rs 744.95 after the company announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Larotrectinib Capsules.
Alembic Pharmaceuticals receives USFDA tentative approval for Larotrectinib Capsules
Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Larotrectinib Capsules, 25 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vitrakvi Capsules, 25 mg and 100 mg, of Bayer Healthcare Pharmaceuticals Inc. (Bayer).