Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets

This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa

Granules India received ANDA approval for Sildenafil for oral suspension

The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million

Zydus receives final approval from the USFDA for Ivabradine Tablets

Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States

AstraZeneca Pharma India receives permission from CDSCO to import new drug

The receipt of this permission paves way for the launch of BREZTRI AEROSPHERE in India

Lupin launches Turqoz (Norgestrel and Ethinyl Estradiol) Tablets in US

Norgestrel and Ethinyl Estradiol Tablets USP (RLD: Lo/Ovral-28) had estimated annual sales of US $33 million in the US

Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension

The product is expected to be launched in FY25

Aurobindo Pharma receives USFDA approval for Darunavir Tablets

Lupin receives tentative approval from USFDA for Canagliflozin Tablets

Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor

Lupin receives approval from USFDA for Bromfenac Ophthalmic Solution

Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain

Strides receives USFDA approval for generic Suprep bowel prep kit

The Product will be manufactured at the company's facility in Bengaluru

Evive Biotech and Acrotech Biopharma receive FDA approval of Ryzneuta

Lupin receives tentative approval from USFDA for Dapagliflozin Tablets

Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US

Lupin receives approval from USFDA for Pitavastatin Tablets

Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol

Truqap plus Faslodex approved in the US for patients with advanced HR-positive breast cancer

First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients

GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia

Decision on EU marketing authorisation expected for momelotinib by early 2024

Strides receives USFDA approval for Levetiracetam Oral Solution

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.

Lupin receives approval from US FDA for Ganirelix Acetate Injection

The product will be manufactured at Lupin’s Nagpur facility in India

Teva announces approval of a generic version of Forteo in US

This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering

FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric

Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer