Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 33
Drug Approval
Drug Approval | 21 March 2022

Zydus receives PAS approval for Mycophenolate Mofetil

The drug is indicated for use in combination with other drugs

Drug Approval
Drug Approval | 21 March 2022

Alembic Pharmaceuticals receives USFDA approval for Lacosamide tablets

The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older

Drug Approval
Drug Approval | 19 March 2022

Jubilant Pharmova arm receives ANDA approval for psychoneurosis drug

The generic version of Sinequan, which is used for the treatment of anxiety, depression, and other target symptoms of psychoneurosis

Drug Approval
Drug Approval | 19 March 2022

USFDA approves Opdualag to treat metastatic melanoma

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab

Drug Approval
Drug Approval | 19 March 2022

USFDA approves Marinus’ treatment for genetic disorder

First and only FDA-approved treatment for seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older

Drug Approval
Drug Approval | 17 March 2022

USFDA approves Rinvoq for ulcerative colitis

First approved in 2019, Rinvoq is a JAK inhibitor approved for four indications across gastroenterology, dermatology and rheumatology

Drug Approval
Drug Approval | 17 March 2022

Lynparza reduced risk of death by 32% in the adjuvant treatment of patients with breast cancer

First PARP inhibitor to demonstrate overall survival benefit in early breast cancer

Drug Approval
Drug Approval | 16 March 2022

Unichem receives ANDA approval for hypertension drug

Nebivolol is used alone or together with other medicines to treat high blood pressure

Drug Approval
Drug Approval | 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)

Drug Approval
Drug Approval | 14 March 2022

USFDA approves Zydus’ Colestipol Hydrochloride tablets

It is only the second generic application approved by the USFDA

Drug Approval
Drug Approval | 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

Drug Approval
Drug Approval | 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

Drug Approval
Drug Approval | 12 March 2022

China approves BeiGene’s tislelizumab

Tislelizumab is now approved for seven indications in China

Drug Approval
Drug Approval | 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

Drug Approval
Drug Approval | 11 March 2022

USFDA approves Lupin’s Vigabatrin oral solution

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

Drug Approval
Drug Approval | 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

Drug Approval
Drug Approval | 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

Drug Approval
Drug Approval | 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)

Drug Approval
Drug Approval | 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

Drug Approval
Drug Approval | 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

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