Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 10
Drug Approval
Drug Approval | 23 October 2024

Zydus receives acceptability from WHO for Typhoid Vi Conjugate Vaccine ZyVac TCV

Company receives acceptability, in principle, for ZyVac TCV making it eligible for purchase by United Nations procurement agencies

Drug Approval
Drug Approval | 21 October 2024

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension

Drug Approval
Drug Approval | 19 October 2024

Zydus receives final approval from USFDA for Fludrocortisone Acetate Tablets USP, 0.1 mg

Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad

Drug Approval
Drug Approval | 19 October 2024

Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets

Granules now has a total of 67 ANDA approvals from the USFDA

Drug Approval
Drug Approval | 18 October 2024

FDA approves VYALEV for adults living with advanced parkinson's disease

VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease

Drug Approval
Drug Approval | 16 October 2024

Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC

Enhertu demonstrated clinically meaningful efficacy in previously treated patients

Drug Approval
Drug Approval | 16 October 2024

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate

GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally

Drug Approval
Drug Approval | 15 October 2024

Lyka’s patent pending Drug Pregabalin Gel 8% w/w receives approval from CDSCO

Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w

Drug Approval
Drug Approval | 14 October 2024

Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3

Indoco is comprehensively working on the remedial action plan

Drug Approval
Drug Approval | 12 October 2024

USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B

HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis

Drug Approval
Drug Approval | 11 October 2024

Zydus receives final approval from USFDA for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg

Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad

Drug Approval
Drug Approval | 11 October 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting

Drug Approval
Drug Approval | 08 October 2024

FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy

Drug Approval
Drug Approval | 06 October 2024

Calquence granted priority review in US for patients with untreated mantle cell lymphoma

Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy

Drug Approval
Drug Approval | 04 October 2024

Shilpa Pharma Lifesciences receives CEP from EDQM for API, Desmopressin

This is used to treat central diabetes insipidus and bedwetting

Drug Approval
Drug Approval | 04 October 2024

Alembic receives USFDA final approval for Alcaftadine Ophthalmic Solution, 0.25% (OTC)

Alcaftadine Ophthalmic Solution, 0.25% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander

Drug Approval
Drug Approval | 04 October 2024

Indoco Remedies receives final ANDA approval from the USFDA for Cetirizine Hydrochloride Tablets

Cetirizine is used for relief of symptoms of hay fever and other allergic conditions

Drug Approval
Drug Approval | 03 October 2024

Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets

Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures

Drug Approval
Drug Approval | 02 October 2024

Zydus receives EIR for the transdermal manufacturing facility

This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated

Drug Approval
Drug Approval | 02 October 2024

Aurobindo Pharma receives USFDA approval for Cephalexin Tablets

The product is expected to be launched in Q3FY25

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