Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 18
Drug Approval
Drug Approval | 07 May 2024

Lupin receives USFDA approval for travoprost ophthalmic solution

Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Drug Approval
Drug Approval | 06 May 2024

Dr. Reddy's Laboratories launches Doxycycline Capsules, 40 mg in US

ORACEA is a trademark of Galderma Holdings, S.A.

Drug Approval
Drug Approval | 06 May 2024

Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals

Eugia Pharma Specialities receives 7 observations from USFDA for Unit II

Drug Approval
Drug Approval | 02 May 2024

FDA grants full approval for TIVDAK to treat cervical cancer

TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer

Drug Approval
Drug Approval | 01 May 2024

Granules India announced ANDA Approval for Colchicine Capsules

Colchicine Capsules are indicated for prophylaxis of gout flares in adult

Drug Approval
Drug Approval | 29 April 2024

AstraZeneca’s Truqap plus Faslodex recommended for approval in the EU by CHMP for cancer treatment

Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%

Drug Approval
Drug Approval | 29 April 2024

Glenmark receives ANDA approval for acetaminophen and ibuprofen tablets

Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics, USA

Drug Approval
Drug Approval | 28 April 2024

Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal

The USFDA has issued 5 observations pursuant to the completion of audit

Drug Approval
Drug Approval | 28 April 2024

Zydus receives final approval from USFDA for Tretinoin Cream

The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)

Drug Approval
Drug Approval | 27 April 2024

CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine

If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU

Drug Approval
Drug Approval | 27 April 2024

Takeda receives positive CHMP opinion for Fruquintinib in previously treated mCRC

If approved in the European Union, Fruquintinib will be the first novel targeted therapy for Metastatic Colorectal Cancer regardless of biomarker status in over a decade

Drug Approval
Drug Approval | 27 April 2024

FDA approves Biktarvy label update with data for pregnant adults with HIV

Additional data in pregnant adults who are Virologically suppressed reinforce safety and tolerability profile of Biktarvy in broad range of people with HIV

Drug Approval
Drug Approval | 23 April 2024

Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings

Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients

Drug Approval
Drug Approval | 23 April 2024

Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines

Approval from Colombia's INVIMA will accelerate growth in Colombia, by registering our product and getting regular supplies

Drug Approval
Drug Approval | 22 April 2024

Lupin launches Mirabegron Extended-Release Tablets in US

Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US

Drug Approval
Drug Approval | 22 April 2024

Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA

NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A

Drug Approval
Drug Approval | 22 April 2024

Zydus launches Mirabegron ER Tablets in the US

Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market

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