Lupin Limited, a global pharmaceutical company headquartered in Mumbai, India, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg. The approval represents an addition to the company’s generic pharmaceutical portfolio in the U.S. market and provides an opportunity to expand access to an established treatment option.
Zydus Lifesciences Limited announced on October 21, 2026, that the United States Food and Drug Administration (USFDA) had granted final approval for its Abbreviated New Drug Application (ANDA) for Estradiol and Levonorgestrel Transdermal System, 0.045 mg/0.015 mg per day. The product is a generic equivalent of Climara Pro, a hormone therapy used in postmenopausal women. The approval expands Zydus’s portfolio of generic pharmaceutical products in the US market.
Biocon has announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Yesintek® (ustekinumab-kfce) as a single-dose prefilled autoinjector. Yesintek® is a biosimilar to Stelara® (ustekinumab), a biologic therapy used across several immune-mediated inflammatory diseases. The approval represents another advancement in Biocon’s expanding biosimilar portfolio and strengthens its presence in the U.S. immunology market.
Zydus Lifesciences has announced that the U.S. Food and Drug Administration (USFDA) has granted final approval for Indocyanine Green for Injection, USP, 25 mg/vial, with eligibility for 180-day Competitive Generic Therapy (CGT) exclusivity. The approval represents an important milestone for the company, reflecting its continued focus on expanding its portfolio of complex injectable generic medicines while addressing areas with limited generic competition. Under the CGT pathway, the first approved applicant receives a period of market exclusivity following commercial launch, encouraging the development of generic medicines for products with inadequate competition.
Lupin Limited has announced the U.S. Food and Drug Administration (FDA) approval and commercial launch of Sugammadex Injection, reinforcing its presence in the U.S. hospital injectable market. Sugammadex is a selective neuromuscular blockade reversal agent used to rapidly reverse the effects of rocuronium bromide and vecuronium bromide during surgical procedures. The approval follows the company’s earlier tentative approval and enables commercial availability in the United States.
Cipla has achieved a significant milestone with the U.S. Food and Drug Administration (USFDA) granting approval for its Abbreviated New Drug Application (ANDA) for the generic version of Advair Diskus® (fluticasone propionate and salmeterol inhalation powder). The approval covers all three strengths—100/50 mcg, 250/50 mcg, and 500/50 mcg—and allows Cipla to market a therapeutically equivalent alternative to one of the most widely prescribed inhaled combination therapies for asthma and chronic obstructive pulmonary disease (COPD).
