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Results For "tentative-approval"

257 News Found

Zydus Cadila receives tentative approval from USFDA for Pemetrexed
News | June 26, 2021

Zydus Cadila receives tentative approval from USFDA for Pemetrexed

Pemetrexed is used to treat certain types of cancers such as lung cancer, mesothelioma. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells


Glenmark receives ANDA tentative approval for Nintedanib Capsules
News | June 26, 2021

Glenmark receives ANDA tentative approval for Nintedanib Capsules

According to IQVIA sales data for the 12 month period ending April 2021, the Ofev Capsules, 100 mg and 150 mg market achieved annual sales of approximately US $1.6 billion


Zydus Cadila receives tentative approval from USFDA for lung cancer drugs
Policy | June 03, 2021

Zydus Cadila receives tentative approval from USFDA for lung cancer drugs

Osimertinib works by slowing or stopping the growth of cancer cells and binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors


Alembic secures USFDA nod for Tretinoin Cream strengthening generics portfolio
Drug Approval | June 14, 2026

Alembic secures USFDA nod for Tretinoin Cream strengthening generics portfolio

The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream


Alembic Pharma receives USFDA nod for generic Levothyroxine sodium tablets
Drug Approval | May 22, 2026

Alembic Pharma receives USFDA nod for generic Levothyroxine sodium tablets

Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism


Lupin gets tentative FDA nod for Revefenacin inhalation solution
Drug Approval | May 20, 2026

Lupin gets tentative FDA nod for Revefenacin inhalation solution

The drug is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)


Shaily gets regulatory nod for launch of ShailyPen Neo device technology
Medical Device | May 20, 2026

Shaily gets regulatory nod for launch of ShailyPen Neo device technology

The product has received tentative USFDA approval, Health Canada notice of compliance, and Indian regulatory approval


OneSource powers second generic semaglutide nod in Canada
Drug Approval | May 05, 2026

OneSource powers second generic semaglutide nod in Canada

Approval marks the second generic semaglutide clearance in Canada and strengthens OneSource’s position in complex injectable CDMO programs


OneSource Specialty Pharma's partners get Health Canada approval for generic Semaglutide injection
News | May 04, 2026

OneSource Specialty Pharma's partners get Health Canada approval for generic Semaglutide injection

Approval for generic Ozempic® in Canada strengthens OneSource’s global CDMO footprint in complex peptide injectable manufacturing


Alembic announces FDA final approval for Fingolimod capsules
Drug Approval | April 27, 2026

Alembic announces FDA final approval for Fingolimod capsules

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)