Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 54
Drug Approval
Drug Approval | 28 December 2021

Aurobindo to manufacture and market molnupiravir

The drug will be marketed under the brand name Molnaflu

Drug Approval
Drug Approval | 28 December 2021

Optimus Pharma to manufacture and market molnupiravir

The company has developed the API in house at its R&D center in Hyderabad

Drug Approval
Drug Approval | 27 December 2021

Covaxin receives approval for Emergency Use in Children 12-18 years

Covaxin is formulated uniquely such that the same dosage can be administered to adults and children

Drug Approval
Drug Approval | 27 December 2021

Lupin receives U.S. FDA approval for Sevelamer Carbonate

This product will be manufactured at Lupin's Goa facility in India

Drug Approval
Drug Approval | 23 December 2021

Pfizer’s Covid-19 pill gets U.S. FDA clearance

Pfizer raises production projections from 80 million to 120 million courses of treatment in 2022, as a result of continued investments to support the manufacturing and distribution of Paxlovid

Drug Approval
Drug Approval | 23 December 2021

U.S. FDA approves Novartis Leqvio to lower cholestrol

With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction1

Drug Approval
Drug Approval | 21 December 2021

CDSCO increases shelf life of Covaxin

The approval of shelf life extension is based on the availability of additional stability data, which was submitted to the CDSCO

Drug Approval
Drug Approval | 21 December 2021

U.S. FDA approves first and only injectable option for HIV prevention

Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition

Drug Approval
Drug Approval | 21 December 2021

NMPA approves CStone's NDA for Cejemly

The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients

Drug Approval
Drug Approval | 21 December 2021

Shilpa Medicare launch Prucalshil for treatment of constipation

Prucalopride medicine in the form of Orally Disintegrating Strips are most convenient dosage form for geriatric patients

Drug Approval
Drug Approval | 21 December 2021

U.S. FDA approves ANI’s rifabutin capsules, launch soon

The capsules are the generic version of the reference listed drug Mycobutin

Drug Approval
Drug Approval | 20 December 2021

Cipla receives final approval for Lanreotide injection

It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours

Drug Approval
Drug Approval | 20 December 2021

WHO grants EUL for Covovax

First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine

Drug Approval
Drug Approval | 16 December 2021

Sun gets US FDA approval for generic amphotericin B injection

It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity

Drug Approval
Drug Approval | 16 December 2021

U.S. FDA approves Bristol Myers Squibb’s Orencia

Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant

Drug Approval
Drug Approval | 11 December 2021

Zydus Pharmaceuticals USA receives tentative approval for schizophrenia drug

The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

Drug Approval
Drug Approval | 10 December 2021

Dr Reddy’s launch Venlafaxine ER tablets in the US

The tablets are available in 150 mg and 225 mg strengths in bottle count sizes of 30 and 90.

Drug Approval
Drug Approval | 10 December 2021

China approves Brii Bio’s antibody combination to neutralise Covid-19

Brii Bio announces amubarvimab/romlusevimab combination received approval from NMPA

Drug Approval
Drug Approval | 09 December 2021

Gland Pharma receives tentative approval for Cangrelor

Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity

Drug Approval
Drug Approval | 09 December 2021

Alembic receives tentative USFDA approval for Selexipag tablets

The tablets are indicated for the treatment of pulmonary arterial hypertension

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