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New Generic Medications Win Approval From FDA.

WASHINGTON -- Apotex Corp. has added a trio of ophthalmic products to its portfolio. The Food and Drug Administration (FDA) recently approved abbreviated new drug applications (ANDAs) for the Florida-based company and those submitted by several other generic drug manufacturers as well.

In addition, generics manufacturers have announced developing and marketing agreements with innovator companies and have received tentative product approvals from the FDA.

And, as part of an expanding trend in the industry, generics companies are devoting additional resources to the branded side of their business operations.

Clearances for Apotex included bextaxolol HCI and levobunolol HCI, both 0.5% solutions. They are the respective generic equivalents to Betoptic and Betagan.

Apotex has also received approval for timolol maleate 0.25% and 0.5% ophthalmic solution, the equivalent to Timoptic.

"These products are an example of our ability to produce high-quality products in all dosage forms," notes president Tammy McIntire.

"Thanks to our state-of-the-art manufacturing facilities, we can introduce generic equivalents like these ophthalmic solutions," she said. "They are evidence of Apotex' ability to bring to the U.S. market high-quality generic products."

All three products will be made at the company's facility in Toronto. Apotex anticipates approval of about two dozen generic products this year.

Other companies with recent ANDA approvals include:

* Barr Laboratories Inc. It has received approval for dextroamphetamine sulfate tablets USP 5 mg and 10 mg, the generic equivalent of Dextrosat, indicated for narcolepsy and attention deficit disorder with hyperactivity. The company has also received clearance for fluvoxamine maleate 25, 50 and 100 mg tablets USP, the equivalent to Luvox, indicated for the treatment of obsessive compulsive disorder.

In addition, Barr has signed a pact with MGI Pharma Inc. for MGI Pharma to begin marketing Mylocel, a proprietary product that will be targeted to oncologists and hematologists.

* Eon Labs Manufacturing Inc. The company has received approval for oxaprozin 600 mg tablets, the first generic for the arthritis medication marketed under the Daypro brand name. Oxaprozin is also Eon's first approval for 2001, according to Frank Della Fera, vice president of sales and marketing.

* Teva Pharmaceutical Industries Ltd. The FDA has approved its nifedipine XL 30 mg and etodolac 400 mg tablets. Nifedipine is the generic version of Procardia XL for the treatment of hypertension and angina; etodolac is the generic version of Lodine XL, indicated for managing signs and symptoms of osteoarthritis and rheumatoid arthritis.

* Watson Pharmaceuticals Inc. The company's Supplemental new drug application for Ferrlecit, its injectable iron therapy product, has been approved. The company has also received approval for Microgestin Fe 1.5/30 and 1/20 tablets, therapeutically equivalent to Loestrin Fe 1.5/30 and 1/20 tablets, indicated for the prevention of pregnancy, and has launched four other branded products: Maxidone, Norco 5.0 mg and Norco 7.5 mg (all pain management products) and Unithroid, a treatment of hypothyroidism.

* Ivax Corp. The company has entered into an agreement with Eli Lilly and Co. to develop and market talampanel, a treatment for seizure disorders. Ivax asserts that the international market for treating seizure disorders is about $3 billion.

* Pharmaceutical Resources Inc. (PRI). Through an alliance with Merck KGaA, PRI will market multiple strengths of fluoxetine tablets pending FDA approval. They will be the generic version of Eli Lilly's Prozac, a treatment for depression.

* Mylan Laboratories Inc. The FDA has tentatively approved Mylan's ANDA for famotidine tablets, 20 mg and 40 mg. The product is generically equivalent to Merck & Co.'s Pepcid. Merck's patent over the ulcer drug is slated to expire April 15. In an attempt to retain market share, that company has launched Pepcid Complete, which can also be used to treat heartburn.
                          U.S. Generic Drug Sales
'96  $7.5
'97  $7.9
'98  $8.2
'99  $9.3
'00 $10.8
'01 $12.9
'02 $14.3
'03 $16.7
'04 $18.7
'05 $21.6
Source: UBS Warburg LLC and IMS Health.
(*.)Year 2000 and beyond are estimates.
                           Drug Price Inflation
                     Brands & Generics -- Total Market
                              2nd Qtr. = 4.4%
'87     6.6%
'88     8.5%
'89     7.9%
'90     8.4%
'91     7.2%
'92     5.9%
'93     3.6%
'94     1.7%
'95     1.9%
'96     1.6%
'97     2.6%
'98     3.2%
'99     4.2%
YTD '00 3.9%
Source: IMS Health.
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Comment:New Generic Medications Win Approval From FDA.
Publication:Chain Drug Review
Article Type:Brief Article
Geographic Code:1USA
Date:Feb 26, 2001
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