Indoco Remedies receives EIR from USFDA for Goa Plant-I

The PAI was conducted for two drug product applications (ANDAs) filed from this facility

Lupin receives USFDA’s approval or Propranolol Hydrochloride Extended-Release Capsules USP

USFDA approves Merck’s Keytruda plus chemoradiotherapy with FIGO 2014 stage III-IVA cervical cancer

Keytruda is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients

USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer

Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy

Jiangsu Vcare files NDA for Vicagrel Capsules with USFDA

Lupin receives tentative approval from USFDA for Dapagliflozin and Saxagliptin tablets

Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of US $5 million in the US

Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24

The company has received five final approvals

Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%

Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis

Eugia Pharma Specialities receives USFDA final approval for Posaconazole Injection

The product is expected to be launched in December 2023

Roche receives USFDA’s priority review to Xolair for food allergies based on positive NIH Phase III study results

If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure