Actualités réglementaires

The FDA has approved ANDA078728 for oral tablets combining glipizide and metformin HCl, manufactured by Heritage Pharmaceuticals.

FDA granted labeling approval for HIKMA Farmaceutica's ciprofloxacin 400 mg/200 mL injection under ANDA078431, with multiple supplemental approvals since 2009.

The FDA has approved ANDA078145 for two injectable ketorolac tromethamine products (15 mg/mL and 30 mg/mL), both listed as discontinued.

FDA records show multiple manufacturing and labeling approvals for Glycine 1.5% irrigation solution (NDA 017633); the product is now discontinued.

The FDA has approved preservative‑free lidocaine hydrochloride injectable products (2% and 4%) under NDA 017584, manufactured by Fresenius Kabi USA.

FDA records show SOLVAY's oral tablet TRANMEP, containing 400 mg meprobamate, is listed as discontinued under application ANDA084369.

On Sep 11, Speaker Jo Jeong‑sik inaugurated the 2nd term Sejong Parliament Building Construction Committee, a 15‑member body that will advise on the new legislative complex.

The FDA has approved ANDA085785 for Sandoz’s oral tablet of trifluoperazine hydrochloride, a prescription drug, with multiple manufacturing and labeling approvals spanning 1982‑1999.

The FDA approved Roche’s ANDA085303 for ENDEP, an oral 150 mg amitriptyline hydrochloride tablet. The product is currently listed as discontinued.

The FDA has approved ANDA 084872 for a 25 mg oral tablet of Meclizine Hydrochloride marketed by BUNDY, with a discontinued marketing status.

The FDA approved ANDA076667 for an over‑the‑counter extended‑release oral tablet containing 60 mg fexofenadine HCl and 120 mg pseudoephedrine HCl, marketed by Dr. Reddy’s.

FDA approved ANDA 076383 for Apotex Inc.'s oral Nizatidine capsules (150 mg and 300 mg) on Jan 23 2003; both products are listed as discontinued.