Latest news and insights on the pharmaceutical industry | Indian Pharma Post
Drug Approval
Drug Approval | 05 October 2022

Lupin receives approval from USFDA for Darunavir Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.

Drug Approval
Drug Approval | 05 October 2022

Casper Pharma receives EIR from USFDA for its PAI

The inspection concluded with no observation (FDA-483) issued.

Drug Approval
Drug Approval | 05 October 2022

Zydus receives USFDA tentative approval for Amantadine Extended-Release capsules

Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data

Drug Approval
Drug Approval | 04 October 2022

Zydus receives approval from USFDA for Mirabegron Extended-Release Tablets

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency

Drug Approval
Drug Approval | 03 October 2022

Lupin gets EIR from USFDA for its Ankleshwar facility

The inspection of the facility was conducted from August 16-19, 2022.

Drug Approval
Drug Approval | 01 October 2022

Zydus receives final approval from the USFDA for Sildenafil for Oral Suspension

Sildenafil for Oral Suspension had annual sales of USD 65 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).

Drug Approval
Drug Approval | 30 September 2022

USFDA inspects Zydus Lifesciences Ahmedabad SEZ facility

The company will address the observations within a stipulated timeline working with the regulators

Drug Approval
Drug Approval | 30 September 2022

Lupin receives US FDA approval for Mirabegron Extended-Release tablets

Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US

Drug Approval
Drug Approval | 30 September 2022

Lupin receives warning letter from US FDA

The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility

Drug Approval
Drug Approval | 30 September 2022

Lupin launches Sildenafil for Oral Suspension in US

Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US

Drug Approval
Drug Approval | 28 September 2022

EDQM grants CEP certificate to Supriya Lifescience for Diphenhydramine Hydrochloride

This will be an added advantage for Supriya Lifescience Limited in the European market.

Drug Approval
Drug Approval | 27 September 2022

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses

Drug Approval
Drug Approval | 24 September 2022

Bausch and Glenmark announce approval of RYALTRIS in Canada

RYALTRIS is a fixed-dose combination therapy that provides relief for the symptoms of SAR, both nasal and ocular, in one easy-to-use nasal spray

Drug Approval
Drug Approval | 23 September 2022

Lupin receives approval from US FDA for Diclofenac Sodium Topical Solution USP

Diclofenac Sodium Topical Solution USP, 2% w/w (RLD Pennsaid) had estimated annual sales of US $484 million in the US

Drug Approval
Drug Approval | 23 September 2022

Lynparza approved in China as first-line maintenance treatment with Bevacizumab for HRD- positive advanced ovarian cancer

One in two women with advanced ovarian cancer has an HRD-positive tumor

Drug Approval
Drug Approval | 22 September 2022

BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin

NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.

Drug Approval
Drug Approval | 22 September 2022

Shilpa Medicare receives tentative approval for Tenofovir Alafenamide Tablets

The ANDA was filed as 'First to File' submission on NCE-1 date.

Drug Approval
Drug Approval | 21 September 2022

Tezspire approved in the EU for the treatment of severe asthma

First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations

Drug Approval
Drug Approval | 21 September 2022

Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19

Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase III treatment trial

Drug Approval
Drug Approval | 19 September 2022

Zydus receives tentative approval from USFDA for Sugammadex Injection

Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery

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