Generics makers keep new products coming

Chain Drug Review, Sept 17, 2007

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WASHINGTON -- Actavis Group has been given approval to market a fentanyl transdermal system in the United States. Actavis' product is the generic equivalent of Duragesic (Alza Pharmaceuticals Inc./Janssen Pharmaceuticals LLP) and is available in 25-, 50-, 75- and 100-meg/hour strengths.

Fentanyl transdermal system is indicated for the management of persistant moderate-to-severe chronic pain that requires round-the-clock opioid administration.

"Approval of fentanyl transderreal system signifies a milestone," maintains president and chief executive officer Robert Wessman.

"Addition of the product is representative of our continued effort to expand the depth and breadth of our product portfolio."

Citing IMS Health data, Actavis says annual brand and generic sales of fentanyl transdermal system for the 12 months ended in June were $1.2 billion in the United States.

Actavis also recently received Food and Drug Administration clearance for generic Inderal capsules. Known by the generic name of propranolol hydrochloride, the extended-release capsules are for the treatment of high blood pressure, management of angina pectoris and prophylaxis of migraines.

Other companies receiving recent Abbreviated New Drug Application approvals include:

* Abraxis Pharmaceutical Products. It was given expedited approval of the first generic cefotetan disodium for injection. The company says the anti-infective has a market potential exceeding $40 million.

* Barr Pharmaceuticals Inc. Portia, its generic oral contraceptive, has been approved and launched in Canada. It is being marketed under an agreement with Apotex Inc.

* Caraco Pharmaceutical Laboratories Ltd. It has been given FDA approval to market a generic version of Zyloprim. Caraco's clearance for allopurinol tablets USP is for strengths of 100- and 300-mg.

* Cipla Ltd. A three-in-one pediatric generics AIDS pill will be marketed by the company. The product combines lamivudine, stavudine and nevirapine, and is the first of its kind for children ages 12 and younger under a global relief program.

* Mylan Laboratories Inc. The company is launching generic Verelan capsules. The drug is used for blocking the movement of calcium into muscle cells of the coronary arteries.

* Ranbaxy Pharmaceuticals Inc. The FDA has given it approval to market several different dosages of hydrocodone bitartrate and acetaminophen, both used to treat moderate-to-moderately severe pain.

* Sandoz. The generic drug unit of Novartis AG has launched metoprolol succinate 50 mg ER (Toprol AG). The product is used to treat angina, heart failure and high blood pressure.

* Teva Pharmaceutical Industries Ltd. It has been given approval of generic Accupril (Pfizer Inc.). Teva's quinapril hydrochloride tablets are available in several strengths.