First-Time Generic Approvals: Inderal LA, Duragesic-12, DuoNeb

Yael Waknine

February 06, 2007

February 6, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for propanolol HCl 60-, 80-, 120-, and 160-mg extended-release capsules in the treatment of hypertension and other conditions; a fentanyl 12.5-µg/hour transdermal system for the management of chronic pain in opioid-tolerant patients; and albuterol sulfate plus ipratropium bromide inhalation solution 3 mg (0.083%)/0.5 mg (0.017%) in 3-mL vials for the management of chronic obstructive pulmonary disease.


Generic Propanolol ER Capsules (Inderal LA) for Hypertension and More


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]
, made by Wyeth Pharmaceuticals, Inc).

According to a company news release, the therapeutically equivalent product is made using Glatt's proprietary CPS pelletization technology for controlled drug release.

Propanolol capsules are indicated for the short-term management of angina pectoris, prophylaxis of common migraine headache, management of hypertrophic subaortic stenosis, and as monotherapy or adjunctive therapy for hypertension.


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.

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