Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 54
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

Drug Approval
Drug Approval | 09 December 2021

USFDA authorises Astra’s antibody cocktail to prevent Covid

Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US to prevent Covid-19

Drug Approval
Drug Approval | 09 December 2021

Dr Reddy’s launch valsartan tablets in the US market

Dr. Reddy's valsartan tablets, USP are available in 40 mg in bottle count size of 30, and 80 mg, 160 mg and 320 mg tablets in bottle count sizes of 90

Drug Approval
Drug Approval | 06 December 2021

Lilly's bamlanivimab with etesevimab authorized for emergency use in Covid-19 patients under 12

Expanded EUA includes both treatment of patients with Covid-19 and post-exposure prophylaxis (PEP) in high-risk pediatric and infant patients

Drug Approval
Drug Approval | 05 December 2021

Morpen gets U.S. FDA approval for Fexofinadine

Fexofinadine is the most widely used, second-generation antihistamine drug for the treatment of allergy symptoms and hay fever

Drug Approval
Drug Approval | 03 December 2021

Unichem Labs gets ANDA approval for schizophrenia medicine

The product will be commercialized from Unichem's Ghaziabad plant

Drug Approval
Drug Approval | 03 December 2021

Biocon Pharma receives ANDA approval for Mycophenolic acid

This further adds to Biocon’s portfolio of vertically integrated complex drug products

Drug Approval
Drug Approval | 30 November 2021

U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery

It is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal

Drug Approval
Drug Approval | 26 November 2021

Aadi Bioscience secures U.S FDA approval of its first product Fyarro

Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa in adults

Drug Approval
Drug Approval | 25 November 2021

ICMR approves Meril’s Rapid Antigen Test kit

The company is marketing the kit under the brand name CoviFind and it can detect the infection in 15 minutes

Drug Approval
Drug Approval | 24 November 2021

U.S. FDA approves first treatment for drug-resistant post-transplant infection

The approval is for Cytomegalovirus, a type of Herpes virus

Drug Approval
Drug Approval | 23 November 2021

Boehringer Ingelheim gets CDSCO nod for Jardiance

Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease

Drug Approval
Drug Approval | 23 November 2021

U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution

The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies

Drug Approval
Drug Approval | 23 November 2021

Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules

Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)

Drug Approval
Drug Approval | 22 November 2021

European Commission approves Roche’s Gavreto

Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people with RET fusion-positive advanced NSCLC

Drug Approval
Drug Approval | 22 November 2021

Amneal gets approval for Difluprednate ophthalmic emulsion

The company is moving towards complex and more differentiated products

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