Regulatory
Regulatory | 16 March 2022

UFDA approves first generic of Symbicort to treat asthma and COPD

This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing)

Regulatory
Regulatory | 14 March 2022

USFDA approves Zydus’ Colestipol Hydrochloride tablets

It is only the second generic application approved by the USFDA

Regulatory
Regulatory | 14 March 2022

Alembic receives USFDA tentative approval for hypertension drug

Macitentan tablets, 10 mg have an estimated market size of US $ 797 million for twelve months ending Dec 2021 according to IQVIA

Regulatory
Regulatory | 14 March 2022

Adlarity receives USFDA approval for treatment of Alzheimer

First and only once-weekly patch for convenient, well-tolerated delivery of most used drug for the treatment of Alzheimer's-related dementia

Regulatory
Regulatory | 12 March 2022

China approves BeiGene’s tislelizumab

Tislelizumab is now approved for seven indications in China

Regulatory
Regulatory | 11 March 2022

Strides receives USFDA approval for Colchicine tablets

Colchicine tablets are used for the treatment and prevention of gout. It reduces inflammation which causes pain, swelling and other symptoms of gout

Regulatory
Regulatory | 11 March 2022

USFDA approves Lupin’s Vigabatrin oral solution

The product will be manufactured at Lupin’s facility in Goa, India

Regulatory
Regulatory | 09 March 2022

USFDA approves Evoke Spinal Cord Stimulation System

Transformative closed-loop technology senses the spinal cord's response to stimulation and instantaneously adjusts therapy to sustain durable, optimized treatment

Regulatory
Regulatory | 08 March 2022

Aleor Dermaceuticals receives USFDA approval for Nystatin and Triamcinolone Acetonide ointment

Nystatin and Triamcinolone Acetonide ointment is indicated for the treatment of cutaneous candidiasis

Regulatory
Regulatory | 07 March 2022

Zydus’ OxemiaTM receives approval from DCGI to treat Anaemia associated with Chronic Kidney Disease

OxemiaTM (Desidustat) is an oral tablet formulation that is the first-in-India alternative to injectable erythropoietin-stimulating agents (ESAs)

Regulatory
Regulatory | 07 March 2022

Jardiance is first and only treatment approved in Europe for chronic heart failure

The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe

Regulatory
Regulatory | 07 March 2022

NATCO launches first generic version of Revlimid in the US

NATCO and Teva are launching these strengths of lenalidomide pursuant to a license of patents owned by Celgene

Regulatory
Regulatory | 06 March 2022

USFDA approves expanded use of Bristol Myers Opdivo

The approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer

Regulatory
Regulatory | 06 March 2022

Johnson & Johnson Vision Care receives USFDA approval for drug-eluting contact lens

Novel technology combines ACUVUE daily disposable contact lenses with an established antihistamine in FDA- first in its new category

Regulatory
Regulatory | 03 March 2022

Lupin receives USFDA approval for topical solution

The product will be manufactured at Lupin’s facility in Pithampur, India

Regulatory
Regulatory | 02 March 2022

USFDA approves first generic version of Apokyn cartridges

TruPharma has commenced commercial marketing of Sage's approved generic cartridge product

Regulatory
Regulatory | 02 March 2022

Amneal enters U.S. biosimilars market with approval of Releukotm

First of three Amneal biosimilars expected for U.S. approval and launch in 2022

Regulatory
Regulatory | 01 March 2022

Lupin launches Sevelamer Hydrochloride tablets in the United States

Sevelamer Hydrochloride tablets, 800 mg is a generic equivalent of Renagel tablets, 800 mg

Regulatory
Regulatory | 01 March 2022

USFDA approves CITI Biopharma’s Vonjo

Vonjo is the first approved therapy to specifically address the needs of adult cytopenic myelofibrosis patients

Regulatory
Regulatory | 28 February 2022

China’s NMPA accepts supplemental NDA for Carteyva

The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China

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