Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 3
Drug Approval
Drug Approval | 26 January 2024

Strides receives USFDA approval for Pregabalin Capsules

The Pregabalin capsules has a market size of ~US$248 mn per IQVIA

Drug Approval
Drug Approval | 23 January 2024

EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome

GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023

Drug Approval
Drug Approval | 20 January 2024

Shilpa Medicare receives Europe approval for Amifampridine Tablets, 10 mg

This product has sales of about US$ 20 million in Europe

Drug Approval
Drug Approval | 19 January 2024

Zydus and Synthon inks licensing and supply agreement for Palbociclib Tablets for US market

Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets

Drug Approval
Drug Approval | 19 January 2024

Lupin receives USFDA’s approval for Febuxostat Tablets

Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)

Drug Approval
Drug Approval | 18 January 2024

Zydus receives USFDA’s approvals for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg

Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis

Drug Approval
Drug Approval | 18 January 2024

Indoco Remedies receives EIR from USFDA for Goa Plant-I

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

Drug Approval
Drug Approval | 13 January 2024

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

Drug Approval
Drug Approval | 11 January 2024

Unichem receives ANDA approval for Doxazosin Tablets

Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure

Drug Approval
Drug Approval | 10 January 2024

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

Drug Approval
Drug Approval | 09 January 2024

European Commission approves Pfizer’s Talzenna in combination with Xtandi for treatment of metastatic castration-resistant prostate cancer

TALZENNA is the first and only PARP inhibitor approved in combination with standard of care XTANDI for mCRPC patients in the European Union

Drug Approval
Drug Approval | 04 January 2024

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

Drug Approval
Drug Approval | 03 January 2024

Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24

The company has received five final approvals

Drug Approval
Drug Approval | 27 December 2023

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

Drug Approval
Drug Approval | 27 December 2023

Eugia Pharma Specialities receives USFDA final approval for Posaconazole Injection

The product is expected to be launched in December 2023

Drug Approval
Drug Approval | 26 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

Drug Approval
Drug Approval | 26 December 2023

Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment

US FDA approval based on NEURO-TTRansform Phase III results

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