Regulatory Updates
Sep 2, 2026•1 min read
FDA Approves Lupin’s CYANOCOBALAMIN Nasal Spray
The FDA granted approval for Lupin Pharmaceuticals' prescription nasal spray containing 0.5 mg per spray of CYANOCOBALAMIN under ANDA210629.
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Regulatory Updates
Sep 2, 2026•1 min read
FDA Approves Methylphenidate Hydrochloride Oral Solution (ANDA 207417)
FDA has approved ANDA 207417 for methylphenidate hydrochloride oral solution, 5 mg/5 mL and 10 mg/5 mL strengths, manufactured by Ascent Pharmaceuticals.
Regulatory Updates
Sep 2, 2026•1 min read
FDA Approves ANDA207047 for Clindamycin Palmitate Hydrochloride
The FDA has approved ANDA207047 for an oral clindamycin palmitate hydrochloride solution (75 mg/5 ml) marketed by Heritage Pharmaceuticals under sponsor APPCO.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA077997 for Caffeine Citrate Intravenous Solution
The FDA has granted approval for ANDA077997, an intravenous caffeine citrate solution manufactured by Fresenius Kabi USA, now listed as a prescription drug.
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Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA077533 for Terbinafine Oral Tablet
The FDA approved ANDA077533 for the oral terbinafine tablet (brand name Terbinafine). Sponsored by Invagen Pharms, the product is now listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Nabumetone (ANDA078420) for Prescription Oral Tablets
The FDA has approved ANDA078420 for Nabumetone tablets (500 mg and 750 mg) marketed by ScieGen Pharmaceuticals, adding a new oral NSAID to the prescription market.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Levetiracetam Oral Solution (ANDA078976)
FDA has approved ANDA078976 for Levetiracetam oral solution, a prescription drug manufactured by Actavis Pharma, Inc., with a detailed submission history.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA084306 for MYDRIACYL (Tropicamide 1% Ophthalmic Solution)
The FDA has approved ANDA084306 for MYDRIACYL, a 1% tropicamide ophthalmic solution marketed by Alcon Laboratories.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves REVONTO (Dantrolene Sodium) Injectable – ANDA078378
The FDA has approved the ANDA for REVONTO, a 20 mg/vial injectable dantrolene sodium product from USWM, LLC, for prescription use.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA 084279 for Probenecid and Colchicine Oral Tablet
The FDA has approved ANDA 084279 for a prescription oral tablet combining 500 mg probenecid and 0.5 mg colchicine, marketed by Actavis Pharma.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA076330 for Octreotide Acetate Injection
The FDA has approved application ANDA076330 for octreotide acetate injectable products manufactured by Hikma Pharmaceuticals, available in two dosage strengths.
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Regulatory Updates
Aug 26, 2026•1 min read
Health Canada recalls Twins Herbal liquids Idakole and Pelorie for undeclared sildenafil
Health Canada has issued a recall of Twins Herbal’s Idakole and Pelorie liquid products, which were sold without market authorization and contain the undeclared prescription drug sildenafil. Consumers should stop use and contact a healthcare provider.