Claritin, Alavert, Advil Allergy Sinus Head Major OTC Approvals In 2002

Antihistamines accounted for the most prominent OTC approvals in 2002, with Schering-Plough Healthcare Products' Claritin franchise and Wyeth Consumer Healthcare's Alavert and Advil Allergy Sinus all receiving the FDA go-ahead during the year.

All three approvals came at the end of 2002. Schering's Claritin products were switched from Rx to OTC use on Nov. 27; Alavert and Advil Allergy Sinus both were approved Dec. 19 (¹ see chart).

The Claritin (loratadine) approvals covered the line's 10 mg tablets, syrup, RediTabs and Claritin-D 12-Hour and 24-Hour products (² (Also see "Schering OTC Claritin Post-Approval Filings To Include Hypospadia Reports" - Pink Sheet, 2 Dec, 2002.), p. 3).

FDA's decision concluded a lengthy debate over OTC availability for the brand that began when WellPoint Health Networks submitted a citizen petition to FDA requesting all second-generation antihistamines be switched to nonprescription status (³ (Also see "OTC Sale Of Rx Allergy Drugs Would Be Safer, Cut Costs - Health Plan" - Pink Sheet, 25 Jan, 1999.), p. 20).

Schering, along with Aventis (which markets Allegra ) and Pfizer ( Zyrtec ), initially opposed switching its antihistamine franchise OTC. The firm argued for maintaining loratadine's Rx status at a joint Nonprescription & Pulmonary-Allergy Drugs Advisory Committee meeting in May 2001.

However, Schering changed course and submitted supplemental NDAs to switch its Claritin products OTC in January 2002. The decision likely was based on a combination of factors, including the pending expiration of Claritin's pediatric exclusivity in December, the introduction of its follow-on drug Clarinex and the filing of 505(b)(2) applications to market loratadine by Wyeth and McNeil Consumer & Specialty Pharmaceuticals.

At its April 2002 review of Schering's switch NDAs for Claritin, NDAC debated whether chronic idiopathic urticaria (chronic hives of an unknown origin) is an appropriate OTC indication.

Based on the committee's recommendations, the agency eventually found OTC Claritin "approvable" for treating hives, a more general indication than CIU. However, FDA said full approval of the indication would depend on the results of a label comprehension study demonstrating consumers "are able to understand how to safely use these drugs to treat hives." OTC Claritin is currently approved only for the treatment of allergic rhinitis.

FDA additionally will review post-marketing safety reports for any potential connection between loratadine and the birth defect hypospadia. The concern did not hinder Claritin's OTC approval because labeling notes women who are pregnant or breast-feeding should consult a doctor before taking the product.

The OTC launch of Claritin in December, however, has not as yet led to a happy new year for Schering. On Jan. 9, the firm lowered its 2002 earnings projections due to a "more rapid than anticipated decline" in Q4 U.S. prescriptions for the antihistamine.

Claritin also faced almost immediate, stiff competition from Wyeth's orally dissolving loratadine product Alavert, which began shipping immediately after its 505(b)(2) application was approved.

Wyeth is attempting to challenge Claritin's strong brand recognition by offering Alavert at a significant discount. The firm also is offering $10-off coupons for Alavert to WellPoint members (⁴ 'The Tan Sheet' Jan. 6, 2003, In Brief).

Generic firms Geneva (tablets), Teva (syrup), Impax (D 12-Hour) and Andrx (D 24-Hour) hold first-to-file status for loratadine and are awaiting ANDA approvals (⁵ (Also see "Schering OTC Claritin Coupons Appearing In Newspapers Dec. 15" - Pink Sheet, 9 Dec, 2002.), p. 4).

McNeil's 505(b)(2) application for loratadine 10 mg tablets was designated "approvable" by FDA in July. The firm has said, however, that it has no plans to launch OTC loratadine "at this time," although it has not withdrawn its application.

Wyeth's other allergy drug approved in 2002 - Advil Allergy Sinus - complements Alavert and gives the firm a more traditional, multi-ingredient product with which to challenge Claritin.

Representing the Advil brand's first three-ingredient combination product (200 mg ibuprofen, 30 mg pseudoephedrine HCl and 2 mg chlorpheniramine maleate), Allergy Sinus is scheduled to reach store shelves in April. Ten- and 20-count packages will retail for $4.59 and $7.99, respectively (⁶ (Also see "Wyeth’s One-Two Allergy Punch: Advil Allergy Sinus To Join Alavert" - Pink Sheet, 6 Jan, 2003.), p. 3).

The product will carry the indication: "temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: runny nose; sneezing; headache; itchy, watery eyes; nasal congestion; minor aches and pains; itching of the nose or throat; sinus pressure; fever."

Wyeth obtained two other Advil approvals during the year - Children's Advil Cold oral suspension (ibuprofen and pseudoephedrine) and Advil Cold & Sinus Liquigels (ibuprofen and pseudoephedrine) (⁷ (Also see "Wyeth Children’s Advil Cold Combination Suspension Extends Pediatric Line" - Pink Sheet, 29 Apr, 2002.), p. 5).

While Schering and Wyeth led the way with five and four NDA approvals in 2002, respectively, several other companies received FDA clearance for new OTC drugs.

GlaxoSmithKline's Commit nicotine polacrilex smoking cessation lozenge was approved Oct. 31 and launched in late November. The mint-flavored product is available in 2 mg and 4 mg strengths. A 72-count retails for about $39.99.

As opposed to the NicoDerm CQ transdermal patch and Nicorette gum, FDA's approval of the Commit lozenge did not stipulate that GSK conduct safety and efficacy studies in adolescents. Instead, the agency said GSK could defer conducting pediatric studies until Oct. 31, 2007 (⁸ (Also see "GSK Commit Lozenge Phase IV Studies On Contraindications, AEs Planned" - Pink Sheet, 4 Nov, 2002.), p. 3).

The nicotine lozenge has sold well in the UK, where it launched roughly a year ago under the brand name NiQuitin CQ . GSK submitted the Commit NDA to the agency in December 2000.

With the Commit lozenge approved for OTC use, an FDA decision about whether Star Scientific's Ariva "cigalett" smokeless tobacco product should be regulated as either an adulterated food or unapproved new drug could be imminent. GSK and several other parties have petitioned FDA to take enforcement action against the product (⁹ (Also see "Ariva “Cigalett” Pieces Are Foods, Not Smokeless Tobacco Items, GSK Says" - Pink Sheet, 4 Mar, 2002.), p. 7).

Pharmacia also is attempting to reinvigorate its Nicotrol brand with the launch of a new tiered-dosing regimen approved by FDA in March. The 15 mg, 10 mg and 5 mg nicotine patches offer an alternative to the original version that provided consumers with a single, 15 mg nicotine dose.

Introduced in the fall, the new Nicotrol products additionally deliver nicotine for 16 hours, instead of 24 hours as with NicoDerm CQ, so that "nicotine can't disturb your sleep." Pharmacia is supporting the brand with a $50 mil. marketing campaign.

Another significant approval in 2002 involved Adams Laboratories' Mucinex guaifenesin tablets. The July 12 agency green light allowed Adams to make its foray into the OTC market.

Approved labeling for the 600 mg guaifenesin extended-release tablets carries the indication: "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."

Adams began selling the product behind pharmacy counters in early September as part of a marketing strategy that relies on physician referrals (¹⁰ (Also see "Adams Labs Mucinex Marketing Strategy Targeting Healthcare Professionals" - Pink Sheet, 22 Jul, 2002.), p. 3). Mucinex is available in 40-count bottles for approximately $25.

Approval of the product prompted FDA to issue 70 warning letters advising manufacturers, distributors, marketers and retailers that Rx single-ingredient guaifenesin extended-release products are now unapproved drugs.

In the Oct. 11 letters, the agency noted that once the Mucinex NDA was cleared, enforcement actions against similar unapproved products became a priority, partly to provide incentive for companies to file formal applications.

OTC approval of Adams' NDA for 1,200 mg guaifenesin extended-release tablets could occur in 2003.

Although FDA approved only one true Rx-to-OTC switch in 2002 (Claritin), the year was filled with significantly more activity than prior years. After clearing four original direct-to-OTC NDAs in 2001, the agency appears to have more than doubled that rate in 2002.

In the coming year, FDA likely will act on AstraZeneca/ Procter & Gamble's NDA for OTC Prilosec (omeprazole). A decision on whether the emergency contraceptive Plan B (levonorgestrel) is appropriate for OTC use could be addressed by NDAC in 2003.

J&J/Merck also has reported that discussions with the agency about possibly switching the cholesterol-lowering statin drug Mevacor are moving in a positive direction (¹¹ (Also see "Mevacor, Ditropan Switch Discussions With FDA Proceeding Well – J&J" - Pink Sheet, 30 Sep, 2002.), p. 3).