Regulatory Updates

The FDA has approved Mylan Pharmaceuticals' fentanyl transdermal extended‑release patches (ANDA076258) in multiple dosage strengths for prescription use.

FDA has approved the generic oral capsule ANAGRELIDE under ANDA076811, covering 0.5 mg and 1 mg strengths, sponsored by Novitum Pharma and manufactured by ANI Pharmaceuticals.

FDA has approved ANDA077099 for ORSYTHIA, an oral tablet containing ethinyl estradiol 0.02 mg and levonorgestrel 0.1 mg, sponsored by PH Health.

The FDA has granted approval for ANDA077405, an oral Ranitidine hydrochloride syrup (15 mg/ml) manufactured by Pharmaceutical Associates, Inc., with labeling updates through 2010.

The FDA has approved ANDA078594 for a 1% ciclopirox prescription shampoo, a topical treatment manufactured by Padagis US.

FDA internal scientists advise against loosening controls on seven peptide ingredients intended for ulcerative colitis, insomnia and obesity, citing insufficient safety data.

The FDA has approved ANDA078299 for Ketorolac Tromethamine injectable (15 mg/mL and 30 mg/mL) from Onesource Specialty, with labeling updates; both products are marked discontinued.

The FDA has listed Quad Pharms' methotrexate sodium injection (product 001) as discontinued under ANDA089309.

The FDA granted original approval for ANDA081189, a 25 mg oral Hydrochlorothiazide tablet from Watson Labs, with multiple labeling supplements approved through 1995. The product is now discontinued.

The FDA records show KV Pharm’s oral tablet of Phendimetrazine Tartrate (35 mg) under ANDA 084138 is now listed as discontinued.

The FDA approved ANDA077533 for the oral terbinafine tablet (brand name Terbinafine). Sponsored by Invagen Pharms, the product is now listed as discontinued.

FDA has approved Chartwell Rx's ANDA077831 for oral CILOSTAZOL tablets in 50 mg and 100 mg strengths, with labeling updates approved in 2016.