On January 26, the FDA approved first-time generic 60-, 80-, 120-, and 160-mg formulations for propanolol HCl extended-release (ER) capsules (made by Par Pharmaceuticals, Inc, and Glatt Pharmaceutical, marketed by Par; brand name Inderal long-acting [LA]
According to a company news release, the therapeutically equivalent product is made using Glatt's proprietary CPS pelletization technology for controlled drug release.
Generic Fentanyl 12.5-µg/hr Patch (Duragesic-12) for Chronic Pain
On January 23, the FDA approved a first-time generic formulation for fentanyl 12.5-µg/hour transdermal system (made by Mylan Technologies, Inc; brand name Duragesic 12 , made by Alza Corp [Johnson & Johnson, Inc]).
According to a company news release, Mylan is the now first generic drugmaker to offer all 5 doses of the patch (12.5, 25, 50, 75, and 100 µg/hr). Immediate shipping of the product is expected.
Fentanyl transdermal systems are indicated for the management of persistent, moderate to severe chronic pain requiring continuous, around-the-clock opioid administration for an extended period of time and which cannot be managed by other means (such as nonsteroidal analgesics, opioid combination products, and immediate-release opioids). The patches should only be used in opioid-tolerant patients.
Generic Albuterol Sulfate/Ipratropium Bromide Inhalation Solution (DuoNeb) for COPD
On December 21, the FDA approved a first-time generic formulation for albuterol sulfate plus ipratropium bromide inhalation solution 3 mg (0.083%)/0.5 mg (0.017%) in 3-mL vials (made by Sandoz, Inc; brand name DuoNeb , made by Dey, Inc [Merck and Co, Inc] ).
Albuterol/ipratropium inhalation solution is indicated for the treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) in patients requiring more than 1 bronchodilator.
Medscape Medical News © 2007 Medscape
Cite this: Yael Waknine. First-Time Generic Approvals: Inderal LA, Duragesic-12, DuoNeb - Medscape - Feb 06, 2007.