Norgestrel and Ethinyl Estradiol Tablets USP (RLD: Lo/Ovral-28) had estimated annual sales of US $33 million in the US
The product is expected to be launched in FY25
Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor
Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain
The Product will be manufactured at the company's facility in Bengaluru
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US
Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol
First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients
Decision on EU marketing authorisation expected for momelotinib by early 2024
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.
The product will be manufactured at Lupin’s Nagpur facility in India
This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
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
Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient
Likmez oral suspension is the first and only FDA-approved liquid option for patients with adherence hurdles such as dysphagia, difficulty swallowing
Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the US (IQVIA MAT August 2023).
This product will be manufactured at Lupin’s Pithampur facility in India
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