Unichem Labs gets US FDA approval for Amitriptyline HCL Tablets
They are indicated for the relief of symptoms of depression
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Drug approvals
Alembic Pharma gets USFDA Final nod for Lurasidone Hydrochloride Tablets
They are indicated for monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode…
Cipla signs licensing deal with Lilly to manufacture and commercialise baricitinib in India
Baricitinib was issued a restricted emergency use approval by CDSCO to treat COVID-19
AstraZeneca gets US FDA nod for FARXIGA to treat chronic kidney disease
In DAPA-CKD Phase III trial, FARXIGA demonstrated reduction in the risk of the composite of worsening of renal function, end-stage…
Hikma Pharma get US FDA nod for higher dosage of naloxone nasal spray to treat opioid overdose
The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity
Glenmark’s Ryaltris nasal spray gets approval in Europe for treatment of allergic rhinitis
It is a novel fixed-dose combination nasal spray of an anti-histamine and a steroid, indicated for the treatment of symptoms…
Biocon Biologics, Viatris get EC approval for biosimilar Bevacizumab
Abevmy 100 and 400 mg is approved for the treatment of metastatic colorectal carcinoma, metastatic breast cancer, non small-cell…
ADC Therapeutics gets USFDA nod for ZYNLONTA to treat relapsed or refractory diffuse large B-cell…
First and only CD19-targeted antibody drug conjugate (ADC) as a single-agent treatment for adult patients with relapsed or…
Zydus Cadila gets EUA from DCGI for hepatitis drug Virafin to treat COVID-19
When administered early on during COVID, Virafin will help patients recover faster and avoid much of the complications, informed…
Alembic Pharma gets USFDA final approval for Doxepin Hydrochloride Capsules
Doxepin Hydrochloride Capsules are recommended for the treatment of depression and anxiety
Zydus Cadila gets final US FDA approval for Propafenone Hydrochloride ER capsules
Propafenone is known as an anti-arrhythmic drug
Gland Pharma gets US FDA nod for generic Foscarnet Sodium Injection, Single-Dose Bag for Infusion
Foscarnet Sodium Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS
Gilead gets US FDA Accelerated Approval for Trodelvy to treat metastatic urothelial cancer
New indication marks secondFDAapproval for Trodelvy in 2021
NATCO gets tentative US FDA approval for Ibrutinib tablets
NATCO feels that it is eligible for 180 days of sole generic marketing exclusivity for all the strengths of the tablet dosage form…
Aleor Dermaceuticals gets tentative USFDA approval for Efinaconazole Topical Solution
It is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton…
Gilead gets US FDA nod for Trodelvy to treat metastatic triple-negative breast cancer
Trodelvy significantly reduced the risk of death by 49 per cent compared with single-agent chemotherapy in the Phase 3 ASCENT…
Zydus Cadila gets final USFDA nod for Macitentan Tablets and eligibility for 180-day shared…
Macitentan is used to manage the symptoms of pulmonary arterial hypertension
Aleor Dermaceuticals gets USFDA nod for Nystatin and Triamcinolone Acetonide Cream
It is indicated for the treatment of cutaneous candidiasis
Evrysdi from ROCHE gets EC nod as home treatment for spinal muscular atrophy
The approval is based on data from two clinical studies, designed to represent a broad spectrum of people living with SMA:…
Bristol Myers Squibb and bluebird bio get US FDA nod for Abecma (idecabtagene vicleucel) to treat…
Abecma is a first-in-class BCMA-directed personalised immune cell therapy delivered as a one-time infusion for triple-class…