Schering-Plough's post-approval commitments for OTC Claritin include submitting to FDA reported cases of the birth defect hypospadia following maternal ingestion of loratadine, the company said.

The quarterly case reports Schering must submit for the first three years following approval also must provide separate analyses of adverse events in children ages two to five and those under age two, according to the company.

On Nov. 27, FDA approved Schering's supplemental NDAs for OTC sale of Claritin 10 mg tablets (NDA 19-658/S-018), syrup (20-704/S-008), RediTabs (20-641/S-009) and Claritin-D 12-Hour (19-670/S-018) and 24-Hour (20-470/S-016).

Claritin tablets, RediTabs and syrup are approved for "temporary relief of symptoms of hay fever or other respiratory allergies: runny nose; sneezing; itchy, watery eyes; and itching of the nose or throat."

In addition to those indications, Claritin-D loratadine/pseudoephedrine combinations are approved for: "relief of nasal congestion"; "temporary reduction of swelling of nasal passages; temporary relief of sinus pressure; and temporary restoration of freer breathing through the nose."

Claritin tablets and RediTabs are approved for use in children as young as age six, while the syrup is approved for use in children as young as age two. The combination decongestant products are cleared for use by people 12 and older.

FDA's Office of Drug Safety and Division of Pulmonary & Allergy Drug Products initiated a review of a possible link between loratadine and hypospadia in May after European regulators announced plans for a similar analysis (¹ Also see "FDA Claritin Hypospadia Review Targeted For Summer Completion" - Pink Sheet, 6 May, 2002., p. 3).

However, in August, the agency said its review of a possible link between loratadine, desloratadine (Schering's Rx follow-on drug Clarinex ) and the birth defect was unlikely to impact its decision to switch Claritin, because many non-Rx products carry labeling restrictions concerning use during pregnancy. The agency's review of hypospadia data is still ongoing.

Approved OTC Claritin labeling states: "If pregnant or breast-feeding, ask a health professional before use."

Schering said it expects non-sedating OTC Claritin will begin reaching store shelves by mid-December, at which time the company will announce an estimated retail price.

However, drug retailer Walgreens is offering consumers an opportunity to pre-order 20-counts of OTC Claritin tablets for $20 (see ² Also see "OTC Claritin $1 Per Tablet Pre-order Price Listed On Walgreens Web Site" - Pink Sheet, 2 December, 2002. ).

Claritin 10 mg tablets, which are taken once a day, will be available in five-, 10-, 20-, 40- and 500-count packages. RediTab labeling was approved in four-, 10- and 30-counts, while packaging for children's fruit-flavored syrup is approved for sale in 4 fl. oz. bottles.

According to approved labeling, Claritin-D 12-Hour will be available in 10- and 20-counts, while Claritin D 24-Hour will be sold in five- and 10-counts.

The principal display panel on approved labeling contains the phrase "Non-Drowsy," followed by an asterisk referring to the statement: "When taken as directed. See Drug Facts Panel."

The "Drug Facts" box advises: "When using this product, do not take more than directed. Taking more than directed may cause drowsiness." Labeling also directs consumers to "ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."

A ³ Schering-Plough press release said the company will support OTC Claritin "with a multi-faceted educational program focusing on allergies, allergy management and potentially associated conditions, such as asthma. The program will also provide allergy sufferers with recommendations about when to remain in close communication with their treating physician."

Although Schering declined to provide details about the budget, timing and other components associated with its advertising, marketing and consumer education campaigns, the company said Ogilvy & Mather Worldwide (New York) will lead the OTC Claritin advertising launch.

FDA approved the OTC switch of Claritin for allergic rhinitis but did not authorize Schering's request for a chronic idiopathic urticaria indication.

Instead, the agency deemed OTC Claritin "approvable" for treating hives - a more general indication than CIU. The agency's findings are consistent with recommendations made by FDA's Nonprescription and Pulmonary-Allergy Drugs Advisory Committees.

In April, committee members found CIU "could be" a disease process appropriate for OTC treatment and that data supported switching Claritin for the indication. However, the panel voiced stronger support for a broader claim encompassing general hives or acute urticaria, even though members found data insufficient to support OTC use of Claritin for the broader claim (⁴ Also see "Loratadine Clinical Trials On General Hives Suggested By NDAC Members" - Pink Sheet, 29 April, 2002., p. 9).

To obtain approval of the hives indication, Schering said it must "provide the results of a label comprehension study or studies that demonstrate consumers are able to understand how to safely use these drugs to treat hives. The label studied should...include language identifying the OTC indication as 'hives,'" as recommended by NDAC.

Schering also must submit labeling with its supplemental NDAs for Claritin tablets, RediTabs and syrup "that is supported by the results of the labeling comprehension study or studies," the firm said.

As expected, Schering did not receive three years of Hatch/Waxman exclusivity for OTC Claritin.

The lack of exclusivity, combined with the firm's initial federal court loss in its efforts to keep generic loratadine off the market pending expiration of patent claims covering desloratadine, opens the door for a slew of ANDA and 505(b)(2) application approvals upon the Dec. 19 expiration of the loratadine compound patent.

The Claritin franchise accounted for $2.7 bil. in U.S. sales in 2001, or 28% of Schering's consolidated worldwide sales. Claritin sales dropped 51% to $402 mil. in the 2002 third quarter and 25% to $1.85 bil. in the nine months due to a significant reduction in trade inventories, conversion of patients to Clarinex and a decline in market share.

In a ⁵ second press release issued Nov. 27, Schering noted even though the CIU indication was not approved OTC, "the company understands that once Claritin OTC is available, all versions of Claritin (branded and generic) will only be allowed to be sold OTC."

The announcement represents a change from statements in S-P's third quarter sales and earnings press release. At that time, the company said it expected "a market transition period during which prescription activity at the patient level will continue" for Claritin. Clarinex is approved for Rx treatment of CIU.

Schering OTC Claritin Post-Approval Filings To Include Hypospadia Reports

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