Zydus receives final approval from USFDA for Theophylline ER Tablets

Theophylline is used to treat asthma and chronic obstructive pulmonary disease

Cipla receives final approval for the generic version of Somatuline Depot Injection

Cipla's Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline Depot (Lanreotide) Injection

Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili

The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States

Glenmark receives ANDA approval for Brimonidine Tartrate and Timolol Maleate ophthalmic solution

According to IQVIATM sales data for the 12-month period ending March 2024, the Combigan Ophthalmic Solution, 0.2%|0.5% market achieved annual sales of approximately $290.0 million

Moderna update on investigational RSV vaccine

U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024

Zydus receives final approval from USFDA for Dexamethasone Tablets

Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)

Strides receives USFDA approval for Sevelamer Carbonate Tablets

Sevelamer Carbonate Tablets approval consolidates the company's position in the Sevelamer segment

Alembic Pharmaceuticals receives 5 USFDA product approvals in Q1 FY25

Receives 3 final and 2 tentative product approvals thus far in Q1FY25

Cipla receives 1 observation from USFDA for Kurkumbh facility

The company is committed to address this observation comprehensively within stipulated time

Gland Pharma receives approval for Edaravone Injection

The product is used to treat amyotrophic lateral sclerosis

USFDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab

Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor

Caplin Point gets Colombia approval for Softgel Capsules

The Unit currently caters to emerging markets of Latin America and Africa with a variety of dosage forms

Alembic Pharmaceuticals receives EIR from USFDA for oncology formulation facility

With this, for all our USFDA facilities, EIRs are in place

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.

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

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

Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals

Eugia Pharma Specialities receives 7 observations from USFDA for Unit II

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

Granules India announced ANDA Approval for Colchicine Capsules

Colchicine Capsules are indicated for prophylaxis of gout flares in adult

Gland Pharma receives approval for cetrorelix acetate for injection

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%