Regulatorische Updates

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

The FDA granted approval for ANDA 088622, an oral 50 mg Amitriptyline Hydrochloride tablet submitted by Watson Labs; the product is listed as discontinued.

MFDS amended the Regulatory Science Innovation Act rules, clarifying its head's authority over R&D project selection and updating agency titles, effective immediately.

The FDA approved Teva’s ANDA 088923 for a 50 mg oral hydrochlorothiazide tablet; the product is listed as discontinued.

Health Canada alerts that Carestation 850 and 850C anesthesia systems may shut down unexpectedly if AC mains power is disconnected or lost.

Gentherm Medical reports overheating in 0.53% of devices, potentially causing shutdowns, but no harm reported.

Health Canada alerts that Carestation 850 and 850C anesthesia systems may shut down unexpectedly when AC mains power is lost.

Gentherm Medical reports that 0.53% of Blanketrol RII 115V and RIII 115V devices have overheated circuit boards, potentially causing shutdowns. No injuries reported; users may continue use with caution.

FDA grants approval for ANDA088292, an oral imipramine hydrochloride tablet by Strides Pharma Science Limited, with details on dosage, NDC codes, and submission history.

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.

Mylan’s ANDA083528 for propoxyphene hydrochloride 32 mg oral capsules is listed as discontinued by the FDA.

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