Actualizaciones regulatorias

FDA granted approval for ANDA079186, a generic Dorzolamide Hydrochloride ophthalmic solution submitted by AM Regent, with original approval in 2009 and a labeling supplement in 2020.

FDA has approved six oral tablet strengths of risperidone (0.25 mg to 4 mg) as prescription products, with labeling updates from 2008 to 2023.

The FDA issued an approval letter for Mylan Pharm Inc.’s topical ciclopirox 8% solution (ANDA 078567), though the product is listed as discontinued.

The FDA has approved application ANDA077370 for generic glimepiride tablets (1‑8 mg) manufactured by Solco Healthcare U.S., LLC and sponsored by Prinston Inc.

FDA approved ANDA077076 submitted by Bedford for Lorazepam injectable products (2 mg/mL and 4 mg/mL), both listed as discontinued.

The Ministry of Health and Welfare announced plans to create a dedicated permanent organization to tackle abnormal fake medical treatments, including fee paybacks and advance high‑cost payments.

SUN PHARM INDS LTD's ANDA076786 for oral Donepezil Hydrochloride tablets (5 mg and 10 mg) has been approved by the FDA, with both products listed as discontinued.

The FDA has approved ANDA 076504 for a prescription fluticasone propionate nasal spray, manufactured by Hikma Pharmaceuticals and Golden State Medical Supply.

The FDA granted approval for ANDA 076233, a Paclitaxel injectable (6 mg/mL) submitted by Hospira. Original approval 2002, labeling supplement 2007.

Expectations for swift pharmacy‑related bill discussions after the National Assembly session have faded as partisan fights over a Justice Minister nominee dominate committees.

Mallinckrodt Inc. received FDA approval for its original Abbreviated New Drug Application (ANDA) 078273 on September 19, 2007.

FDA approves ANDA 077973 for Synthon Pharm’s 50 mg oral bicalutamide tablet; labeling approved in 2009 and manufacturing in 2011.