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Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA FDA
February 18, 2022
In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency’s recommendations...
FDA issues series of guidances under Drug Competition Action Plan FDA
January 28, 2022
This week, FDA published a series of guidances focused on generic drug application submissions, labeling, and review. These guidances are part of our continued efforts to bring greater efficiency and transparency to the generic drug review process...
Advancing Generic Drug Development: Translating Science to Approval fda.gov
August 25, 2021
The purpose of the public workshop is to communicate how outcomes from FDA research conducted under the Generic Drug User Fee Amendments (GDUFA) guide and facilitate generic drug development, regulatory assessment, and approval.
Alembic Pharmaceuticals gets USFDA final approval for Erlotinib Tablets expresspharma
July 09, 2021
Erlotinib Tablets are indicated for the treatment of patients with metastatic non-small cell lung cancer and locally advanced, unresectable or metastatic pancreatic cancer.
FDA Publishes Product-Specific Guidelines for Generic Drug Development americanpharmaceuticalreview
May 21, 2021
The FDA published a new batch of product-specific guidelines (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval.
Zydus Cadila gets final USFDA nod for Macitentan Tablets and eligibility for 180-day shared exclusivity expresspharma
April 09, 2021
Macitentan is used to manage the symptoms of pulmonary arterial hypertension.
Aleor Dermaceuticals gets tentative USFDA approval for Efinaconazole Topical Solution expresspharma
April 09, 2021
It is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
Amphastar Receives FDA Approval for Dextrose Injection americanpharmaceuticalreview
March 30, 2021
Amphastar Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved the Company’s Abbreviated New Drug Application (ANDA) for Dextrose injection 50% in the 50 mL Luer-Jet® Prefilled Syringe System.
Glenmark Pharma gets ANDA approval for diltiazem hydrochloride ER capsules expresspharma
March 24, 2021
Glenmark has been granted a competitive generic therapy (CGT) designation for Diltiazem hydrochloride extended release capsules USP, 60 mg, 90 mg, and 120 mg.
Shilpa Medicare gets US FDA tentative nod for Apremilast Tablets expresspharma
March 05, 2021
Shilpa Medicare has received US Food and Drug Administration (US FDA) tentative approval for its ANDA, Apremilast Tablets, 10 mg, 20 mg, and 30 mg dated 04 Mar 2021.

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