Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics, USA
The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
Approval from Colombia's INVIMA will accelerate growth in Colombia, by registering our product and getting regular supplies
This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy
Tacrolimus is an immunosuppressant used in the treatment of organ transplant patients
Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly
The Product is expected to be the first generic approval on the market
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