Drug Approval | June 14, 2026
Alembic secures USFDA nod for Tretinoin Cream strengthening generics portfolio
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.
The approved product is therapeutically equivalent to Haldol tablets of Ortho McNeil Pharmaceutical
Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval
This facility plays an important role in Granules’ global manufacturing and supply network
Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism
Antiviral injection addressing CMV and HSV infections had US market sales of nearly $15 million in the last 12 months
Famotidine Injection USP is a generic version of Pepcid injection to be manufactured at its Nagpur facility for the U.S. market
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
Fresenius Kabi's approved generic therapy addresses acute symptomatic hypocalcemia and targets a US market valued at nearly $71 million
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