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75756 Federal Register / Vol. 71, No. 242 / Monday, December 18, 2006 / Notices
FEDERAL TRADE COMMISSION paper or electronic form, will be Pfizer’s Zantac H–2 blocker business;
considered by the Commission, and will (2) Pfizer’s Cortizone hydrocortisone
[File No. 061 0220, Docket No. C–4180]
be available to the public on the FTC anti-itch business; (3) Pfizer’s Unisom
Johnson & Johnson and Pfizer Inc.; Web site, to the extent practicable, at nighttime sleep-aid business; and (4)
Analysis of Agreement Containing http://www.ftc.gov. As a matter of J&J’s Balmex diaper rash treatment
Consent Orders To Aid Public discretion, the FTC makes every effort to business.
Comment remove home contact information for The proposed Consent Agreement has
individuals from the public comments it been placed on the public record for
AGENCY: Federal Trade Commission. receives before placing those comments thirty (30) days for receipt of comments
ACTION: Proposed Consent Agreement. on the FTC Web site. More information, by interested persons. Comments
including routine uses permitted by the received during this period will become
SUMMARY: The consent agreement in this part of the public record. After thirty
Privacy Act, may be found in the FTC’s
matter settles alleged violations of privacy policy, at http://www.ftc.gov/ (30) days, the Commission will again
Federal law prohibiting unfair or review the proposed Consent Agreement
ftc/privacy.htm.
deceptive acts or practices or unfair and will decide whether it should
methods of competition. The attached FOR FURTHER INFORMATION CONTACT:
Michael R. Moiseyev, Bureau of withdraw from the proposed Consent
Analysis to Aid Public Comment Agreement, modify it, or make final the
describes both the allegations in the Competition, 600 Pennsylvania Avenue,
NW., Washington, DC 20580, (202) 326– Decision and Order (‘‘Order’’).
draft complaint and the terms of the Pursuant to a Stock and Asset
consent order—embodied in the consent 3106.
Purchase Agreement dated June 25,
agreement—that would settle these SUPPLEMENTARY INFORMATION: Pursuant 2006, J&J proposes to acquire certain
allegations. to section 6(f) of the Federal Trade voting securities and assets comprising
Commission Act, 38 Stat. 721, 15 U.S.C. Pfizer’s Consumer Healthcare business
DATES: Comments must be received on
46(f), and § 2.34 of the Commission in a transaction valued at approximately
or before January 11, 2007.
Rules of Practice, 16 CFR 2.34, notice is $16.6 billion (‘‘Proposed Acquisition’’).
ADDRESSES: Interested parties are
hereby given that the above-captioned The Commission’s complaint alleges
invited to submit written comments. consent agreement containing a consent
Comments should refer to ‘‘Johnson & that the Proposed Acquisition, if
order to cease and desist, having been consummated, would violate section 7
Johnson and Pfizer, File No. 061 0220,’’ filed with and accepted, subject to final
to facilitate the organization of of the Clayton Act, as amended, 15
approval, by the Commission, has been U.S.C. 18, and section 5 of the Federal
comments. A comment filed in paper placed on the public record for a period
form should include this reference both Trade Commission Act, as amended, 15
of thirty (30) days. The following U.S.C. 45, by lessening competition in
in the text and on the envelope, and Analysis to Aid Public Comment
should be mailed or delivered to the the United States markets for the
describes the terms of the consent research, development, manufacture,
following address: Federal Trade agreement, and the allegations in the
Commission/Office of the Secretary, distribution, and sale of the following
complaint. An electronic copy of the over-the-counter (‘‘OTC’’) medications:
Room 135–H, 600 Pennsylvania full text of the consent agreement
Avenue, NW., Washington, DC 20580. (1) H–2 blockers, (2) hydrocortisone
package can be obtained from the FTC anti-itch products, (3) nighttime sleep-
Comments containing confidential Home Page (for December 12, 2006), on
material must be filed in paper form, aids, and (4) diaper rash treatments (the
the World Wide Web, at http:// ‘‘Products’’).
must be clearly labeled ‘‘Confidential,’’ www.ftc.gov/os/2006/12/index.htm. A
and must comply with Commission paper copy can be obtained from the II. The Parties
Rule 4.9(c). 16 CFR 4.9(c) (2005).1 The FTC Public Reference Room, Room 130– J&J is one of the largest and most
FTC is requesting that any comment H, 600 Pennsylvania Avenue, NW., diversified suppliers of branded
filed in paper form be sent by courier or Washington, DC 20580, either in person consumer health care products in the
overnight service, if possible, because or by calling (202) 326–2222. world, as well as a manufacturer and
U.S. postal mail in the Washington area Public comments are invited, and may supplier of pharmaceuticals, medical
and at the Commission is subject to be filed with the Commission in either devices, and diagnostic products. In
delay due to heightened security paper or electronic form. All comments 2005, J&J had worldwide net sales of
precautions. Comments that do not should be filed as prescribed in the $50.5 billion. The more than 230 J&J
contain any nonpublic information may ADDRESSES section above, and must be operating companies employ
instead be filed in electronic form as received on or before the date specified approximately 116,000 individuals in
part of or as an attachment to e-mail in the DATES section. 57 countries and sell products
messages directed to the following e- throughout the world. In the consumer
mail box: consentagreement@ftc.gov. I. Analysis of Agreement Containing products segment, J&J manufactures and
The FTC Act and other laws the Consent Order To Aid Public Comment markets a broad range of OTC
Commission administers permit the The Federal Trade Commission medications, women’s health products,
collection of public comments to (‘‘Commission’’) has accepted, subject to nutritional products, oral care products,
consider and use in this proceeding as final approval, an Agreement and products used for baby and skin
appropriate. All timely and responsive Containing Consent Orders (‘‘Consent care. With its Pepcid line of products,
public comments, whether filed in Agreement’’) from Johnson & Johnson J&J is the leading supplier of OTC H–2
1 The comment must be accompanied by an
(‘‘J&J’’) and Pfizer Inc. (‘‘Pfizer’’), which blocker acid relief products in the
explicit request for confidential treatment,
is designed to remedy the United States. J&J is also a leading
including the factual and legal basis for the request, anticompetitive effects that would supplier of OTC hydrocortisone-based
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and must identify the specific portions of the otherwise result from J&J’s proposed anti-itch medications under its Cortaid
comment to be withheld from the public record. acquisition of Pfizer Consumer and Aveeno brands and of OTC
The request will be granted or denied by the
Commission’s General Counsel, consistent with
Healthcare. Under the terms of the nighttime sleep-aids under its Simply
applicable law and the public interest. See proposed Consent Agreement, the Sleep brand. J&J is also a leading
Commission Rule 4.9(c), 16 CFR 4.9(c). parties will be required to divest: (1) supplier of products for treating diaper
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Federal Register / Vol. 71, No. 242 / Monday, December 18, 2006 / Notices 75757
rash under its Balmex, Aveeno, and AR—and private label versions of account for a significant share of the
Johnson’s No More Rash brands. some Pepcid, Zantac, and Tagamet market. Pfizer’s Cortizone is the market
Pfizer is one of the largest products. J&J and Pfizer are the two leader among branded products, while
pharmaceutical companies in the world. largest suppliers in this market. J&J’s Cortaid is the second leading
Pfizer researches, develops, The Proposed Acquisition would branded product line. In 2005, sales of
manufactures, and markets leading significantly increase market OTC hydrocortisone anti-itch products
prescription medicines for humans and concentration and eliminate substantial in the United States totaled
animals, as well as consumer healthcare competition between the two leading approximately $120 million.
products. In 2005, Pfizer had worldwide suppliers of OTC H–2 blockers in the The Proposed Acquisition would
net sales of $51.3 billion. Pfizer United States. Branded manufacturers of significantly increase market
Consumer Healthcare, which J&J these products spend significant sums concentration and eliminate substantial
proposes to acquire, is a global business of money annually to create and competition between the two leading
that researches, develops, manufactures, maintain distinct brand equities. As a suppliers of OTC hydrocortisone anti-
and markets many well-known brands result of the acquisition, J&J would itch products in the United States. As a
of OTC medications and oral care account for over 70% of the sales of result of the acquisition, J&J would
products to consumers throughout the OTC H–2 blocker in the United States. account for over 55% of the sales of
world. In 2005, Pfizer Consumer Here the evidence confirmed that OTC hydrocortisone anti-itch products
Healthcare generated net sales of $3.9 Pepcid and Zantac are close in the United States. Evidence indicates
billion. Like J&J, Pfizer is one of the substitutes. Consumers have benefitted that the parties’ products compete on
leading suppliers of OTC H–2 blocker from the competition between Pfizer many levels, including pricing, shelf-
acid relief products in the United States and J&J on pricing, discounts, space, and advertising. By eliminating
with its Zantac product line. Pfizer is promotional trade spending, and competition between the two leading
also the leading supplier in the United product innovation. Thus, unremedied, branded suppliers, the Proposed
States of OTC hydrocortisone anti-itch the Proposed Acquisition likely would Acquisition would likely result in
medications under its Cortizone brand, cause significant anticompetitive harm higher prices, less promotional
OTC nighttime sleep-aids under its by enabling J&J to profit by unilaterally spending, and reduced product
Unisom brand, and diaper rash raising the prices of one or both innovation. Although private label OTC
products under its Desitin brand. products above pre-merger levels, as hydrocortisone anti-itch products
well as reducing its incentives to account for a significant share of the
III. OTC H–2 Blockers
innovate and develop new products. market, private label products are less
One of the relevant markets in which close substitutes for a significant share
to assess the competitive effects of the IV. OTC Hydrocortisone Anti-Itch
of customers, and it is unlikely that
Proposed Acquisition is the United Products
private label products would be able to
States market for OTC H–2 blockers. H2- A second relevant product market in reposition themselves to replace the
receptor antagonists, more commonly which to assess the competitive effects competition between J&J and Pfizer, the
known as ‘‘H–2 blockers,’’ are a class of of the Proposed Acquisition is the two largest branded competitors in this
drugs for the prevention and relief of United States market for OTC market, that would be lost through the
heartburn associated with acid hydrocortisone anti-itch products. Proposed Acquisition. Thus,
indigestion. Originally a prescription Hydrocortisone is a corticosteroid that unremedied, the Proposed Acquisition
medicine, H–2 blocker products were reduces or inhibits the actions of likely would cause significant
later approved by the FDA for sale chemicals in the body that cause anticompetitive harm by enabling J&J to
without a prescription. H–2 blockers inflammation, redness and swelling. profit by unilaterally raising the prices
work by blocking histamine from OTC products containing up to 1.0 of one or both products above pre-
stimulating the gastric parietal cells, percent hydrocortisone are approved by merger levels, as well as reducing its
thereby suppressing secretion of the FDA for topical application to treat incentives to innovate and develop new
stomach acid. Although there are other minor skin irritations, itching, and products.
OTC acid relief medications, including rashes due to various conditions,
antacids and proton pump inhibitors including dermatitis, eczema, and V. OTC Nighttime Sleep-Aids
(‘‘PPIs’’), H–2 blockers are sufficiently psoriasis. Although OTC topical A third relevant product market in
different from these other products that anesthetic and antihistamine products which to assess the competitive effects
they are not close economic substitutes. are available to treat minor skin of the Proposed Acquisition is the
Currently, Prilosec OTC is the only PPI irritations, itching and rashes, these United States market for OTC nighttime
available without a prescription. OTC products are not close economic sleep-aids. OTC nighttime sleep-aids are
PPIs are not a close substitute for OTC substitutes for hydrocortisone anti-itch non-prescription drugs that are
H–2 blockers because they are indicated products because they work differently indicated solely for the relief of
for the relief of chronic heartburn and than hydrocortisone products. While occasional sleeplessness by individuals
not for immediate relief of occasional these products may relieve symptoms of who have difficulty falling asleep. The
heartburn or indigestion. Antacid tablets pain or itching, unlike hydrocortisone, active ingredient in the best-selling
and liquids are not a close substitute for they do nothing to cure or prevent the sleep-aids is a sedating antihistamine,
OTC H–2 blockers because they are less actual underlying skin conditions such such as diphenhydramine
efficacious and do not provide as long as eczema or psoriasis. hydrochloride or doxylamine succinate.
relief as H–2 blockers. The United States market for OTC Prescription sleep-aids, such as
The United States market for OTC H– hydrocortisone anti-itch products is zolpidem (Ambien), zaleplon
2 blockers is highly concentrated. highly concentrated. There are only two (Sonata) or eszopiclone (Lunesta), are
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Today, this approximately $360 million significant branded competitors in this not close economic substitutes for OTC
market comprises four branded market: (1) Pfizer, with its Cortizone nighttime sleep-aids. Consumers of OTC
products—J&J’s Pepcid, Pfizer’s products and (2) J&J, with its Cortaid nighttime sleep-aids likely would not
Zantac, GlaxoSmithKline’s Tagamet, products. In addition, private label switch to prescription sleep-aids in
and Reliant Pharmaceutical’s Axid hydrocortisone anti-itch products response to a 5 to 10 percent increase
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75758 Federal Register / Vol. 71, No. 242 / Monday, December 18, 2006 / Notices
in the price of OTC nighttime sleep-aids zinc oxide and (2) ointments containing Developing and obtaining Food and
because of the higher prices of the active ingredient petrolatum. There Drug Administration approval for the
prescription sleep-aids (particularly for are no close substitutes for OTC diaper manufacture and sale of a novel,
those without insurance coverage) and rash creams or ointments. differentiated medication takes at least
the inconvenience and cost of a doctor’s The United States market for OTC two (2) years. Once product
visit (including delays for consumers diaper rash treatments is highly development is complete, a new entrant
who have exhausted their concentrated. Today, three large, must invest extremely high sunk costs
prescriptions). established brands—Pfizer’s Desitin, on marketing, advertising, and
The United States market for OTC Schering-Plough’s A&D, and J&J’s promotional allowances to create and
nighttime sleep-aids is highly Balmex—account for over 70% of sales maintain consumer awareness and
concentrated. J&J and Pfizer are the two in this approximately $84 million acceptance of the new product. Given
largest suppliers of branded OTC market. The rest of the market is the sales opportunities available in the
nighttime sleep-aids in the United composed of several small, niche markets for the Products, coupled with
States. Pfizer is the market leader with brands. Private label products account the significant investment necessary to
its Unisom products, while J&J is the for a negligible share of the market. market and sell the Products, it is
second leading supplier with its Simply Pfizer is the largest supplier of OTC unlikely that a new competitor will
Sleep products. In 2005, sales of OTC diaper rash treatment products with its enter any of the markets for the
nighttime sleep-aids in the United Desitin line of products, while J&J is Products.
States totaled approximately $100 the third largest supplier with its
million. Balmex, Aveeno, and Johnson’s No VIII. The Consent Agreement
The Proposed Acquisition would More Rash brands. Neither the The Consent Agreement effectively
significantly increase market Aveeno nor the Johnson’s No More remedies the Proposed Acquisition’s
concentration and eliminate substantial Rash brands, however, account for a anticompetitive effects in the relevant
competition between the two leading significant share of sales in this market. markets discussed above. The Consent
suppliers of OTC nighttime sleep-aids in The Proposed Acquisition would Agreement preserves competition in
the United States. As a result of the significantly increase market these markets by requiring the
acquisition, J&J would account for over concentration and eliminate substantial divestiture of: (1) All assets related to
45% of the sales of OTC nighttime competition between the two leading the Zantac H–2 blockers to Boehringer
sleep-aids in the United States. In suppliers of OTC diaper rash treatment Ingelheim Pharmaceuticals, Inc.
addition, the evidence confirmed that products in the United States. As a (‘‘Boehringer Ingelheim
Unisom and Simply Sleep are close result of the acquisition, J&J would Pharmaceuticals’’); and (2) all assets
substitutes and have similar efficacy, account for nearly 50% of the sales of relating to Cortizone hydrocortisone
brand equity, and brand positioning. OTC diaper rash treatment products in anti-itch products, all assets relating to
Consumers have benefitted from the the United States. Although there are Unisom sleep-aids, and all assets
competition between Pfizer and J&J on additional suppliers of branded OTC relating to Balmex diaper rash
pricing, discounts, promotional trade diaper rash treatment products in this treatment products to Chattem, Inc.
spending, and product innovation. market, the evidence confirmed that (‘‘Chattem’’) (the ‘‘Divested Assets’’).
Although private label OTC nighttime Desitin and Balmex are perceived to These divestitures must take place
sleep-aids account for a significant share be close substitutes by consumers, and within fifteen days after the closing of
of the market, private label products are evidence suggests that they are similar the Proposed Acquisition or January 2,
less close substitutes for a significant in formulation, texture, and appearance. 2007, whichever is later.
share of customers, and it is unlikely Consumers have benefitted from the The Commission is satisfied that
that private label products would competition between Pfizer and J&J on Boehringer Ingelheim Pharmaceuticals
reposition themselves to replace the pricing, discounts, promotional trade is a well-qualified acquirer of the Zantac
competition between J&J and Pfizer, the spending, and product innovation. business. Boehringer Ingelheim
two largest branded competitors in this Thus, unremedied, the Proposed Pharmaceuticals engages in the
market, that would be lost through the Acquisition likely would cause research, development, sale and
Proposed Acquisition. Thus, significant anticompetitive harm by marketing of branded pharmaceuticals
unremedied, the Proposed Acquisition enabling J&J to profit by unilaterally and OTC drugs, including well known
likely would cause significant raising the prices of one or both brands such as Dulcolax, Spiriva,
anticompetitive harm by enabling J&J to products above pre-merger levels, as Atrovent, Combivent, Flomax and
profit by unilaterally raising the prices well as reducing its incentives to Mirapex. Boehringer Ingelheim
of one or both products above pre- innovate and develop new products. Pharmaceuticals is part of the
merger levels, as well as reducing its Boehringer Ingelheim Group, which is a
VII. Entry leading worldwide manufacturer of
incentives to innovate and develop new
products. Entry into the markets for the pharmaceuticals for humans and
research, development, manufacture, animals and the eighth largest
VI. OTC Diaper Rash Treatments and sale of the Products is unlikely to manufacturer and marketer of OTC
A fourth relevant product market in deter or counteract the anticompetitive health care products worldwide.
which to assess the competitive effects effects of the Proposed Acquisition. Boehringer Ingelheim Pharmaceutical’s
of the Proposed Acquisition is the Each of the relevant markets is relatively Consumer Health Care business has an
United States market for OTC diaper mature and dominated by a few well- existing sales and distribution network
rash treatment products. Consumers use established brand names. In such a that sells products through the same
diaper rash creams or ointments to treat market environment, a new entrant channels as Zantac is currently sold,
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and prevent diaper rash and to protect faces a difficult task of convincing and has a strong record of integrating
sore or chafed skin from moisture or retailers to carry its product, especially product acquisitions successfully.
irritation. Most diaper rash products fall if the new product does not have a The proposed Consent Agreement
into one of two categories: (1) Creams or competitive advantage based on contains several provisions designed to
pastes containing the active ingredient differentiated claims or efficacy. ensure the successful divestiture of the
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Federal Register / Vol. 71, No. 242 / Monday, December 18, 2006 / Notices 75759
Zantac business to Boehringer Assets for the brief transition period summaries of proposed projects. To
Ingelheim Pharmaceuticals by requiring between the time the Commission request more information on the
that: (1) J&J divest to Boehringer approves the proposed Order and when proposed projects or to obtain a copy of
Ingelheim Pharmaceuticals all assets the divestitures take place, which will the data collection plans and
relating to Pfizer’s Zantac line of not be later than January 2, 2007. Even instruments, call 404–639–5960 and
products, including all research and though such a period is relatively short, send comments to Seleda Perryman,
development, intellectual property, and maintenance of current supply, CDC Assistant Reports Clearance
customer and supply contracts; (2) J&J advertising and promotional levels and Officer, 1600 Clifton Road, MS–D74,
and Pfizer take steps to ensure that activities at all times prior to divestiture Atlanta, GA 30333 or send an e-mail to
confidential business information is of paramount importance. The omb@cdc.gov.
relating to Zantac will not be obtained proposed Consent Agreement Comments are invited on: (a) Whether
or used by J&J; (3) Boehringer Ingelheim incorporates this plan in the Order to the proposed collection of information
Pharmaceuticals have the opportunity to Maintain Assets, detailing requirements is necessary for the proper performance
enter into employment contracts with for the assets that must be held separate, of the functions of the agency, including
certain key individuals who have services that may be shared with the whether the information shall have
experience relating to Zantac; and (4) ongoing business, and the employee practical utility; (b) the accuracy of the
certain management employees of Pfizer positions that are necessary for the held agency’s estimate of the burden of the
who were substantially involved in the separate business. proposed collection of information; (c)
research, development or marketing of The Commission has appointed David ways to enhance the quality, utility, and
Zantac be precluded from working on Painter of LECG as Interim Monitor to clarity of the information to be
competitive H–2 blocker products at J&J oversee the transfer of assets, the collected; and (d) ways to minimize the
for a period of two years.2 establishment of appropriate firewalls to burden of the collection of information
The Commission is also satisfied that prevent the transfer or use of on respondents, including through the
Chattem is a well-qualified acquirer of confidential business information and to use of automated collection techniques
the Cortisone, Unisom, and Balmex ensure that J&J and Pfizer comply with or other forms of information
businesses. Chattem is a leading all other provisions of the Order. To technology. Written comments should
manufacturer and marketer of a broad ensure that the Commission remains be received within 60 days of this
portfolio of branded OTC healthcare informed about the status of the notice.
products, toiletries, and dietary Divested Assets and their transfer, the Proposed Project
supplements, including brands such as proposed Consent Agreement requires
Pilot Project for a National Monitoring
Icy Hot, Gold Bond, Selsun blue, J&J and Pfizer to file reports with the
System for Major Adverse Effects of
Garlique, Pamprin, and BullFrog. Commission periodically until the
Medication Use During Pregnancy and
Chattem’s products are among the divestitures are accomplished.
Lactation—New—National Center on
market leaders in their respective The purpose of this analysis is to
Birth Defects and Developmental
categories across food, drug and mass facilitate public comment on the
Disabilities (NCBDDD), Centers for
merchandisers. Chattem has an proposed Consent Agreement, and it is
Disease Control and Prevention (CDC).
experienced sales force with existing not intended to constitute an official
relationships with major retailers and interpretation of the proposed Decision Background and Brief Description
has a strong record of integrating prior and Order or the Order to Maintain This data collection is based on the
product acquisitions successfully. Assets, or to modify their terms in any following components of the Public
The proposed Consent Agreement way. Health Service Act: (1) Act 42 U.S.C.
contains several provisions designed to By direction of the Commission with 241, Section 301, which authorizes
ensure the successful divestiture of the Commissioners Harbour, Kovacic and Rosch ‘‘research, investigations, experiments,
Cortisone, Unisom, and Balmex recused. demonstrations, and studies relating to
businesses to Chattem by requiring that: Donald S. Clark, the causes, diagnosis, treatment, control,
(1) J&J divest to Chattem all assets Secretary. and prevention of physical and mental
relating to the Cortisone, Unisom, diseases and impairments of man.’’ (2)
[FR Doc. E6–21519 Filed 12–15–06; 8:45 am]
and Balmex line of products, 42 U.S.C. 247b–4, Section 317 C, which
BILLING CODE 6750–01–P
including all research and development, authorizes the activities of the National
intellectual property, and customer and Center on Birth Defects and
supply contracts; (2) J&J and Pfizer take Developmental Disabilities. This section
steps to ensure that confidential DEPARTMENT OF HEALTH AND
HUMAN SERVICES was created by Public Law 106–310,
business information relating to also known as ‘‘the Children’s Health
Cortisone, Unisom, and Balmex Act of 2000.’’ This portion of the code
Centers for Disease Control and
will not be obtained or used by J&J; and has also been amended by Public Law
Prevention
(3) Chattem have the opportunity to 108–154, which is also known as the
enter into employment contracts with [60Day–07–07AA]
‘‘Birth Defects and Developmental
certain key individuals who have Disabilities Prevention Act of 2003’’.
experience relating to Cortisone, Proposed Data Collections Submitted
for Public Comment and The use of a number of medications
Unisom, and Balmex. during pregnancy is known to be
The Order to Maintain Assets that is Recommendations
associated with serious adverse effects
included in the proposed Consent In compliance with the requirement in children. However, because pregnant
Agreement requires that J&J and Pfizer of Section 3506(c)(2)(A) of the and lactating women are traditionally
jlentini on PROD1PC65 with NOTICES
maintain the viability of the Divested Paperwork Reduction Act of 1995 for excluded from clinical trials, and
2 This firewall will prevent J&J from taking
opportunity for public comment on because premarketing animal studies do
competitive advantage of know-how, product
proposed data collection projects, the not necessarily predict the experience of
development, marketing, and sales plans relating to Centers for Disease Control and humans, little information is available
Zantac. Prevention (CDC) will publish periodic about the safety of most prescription
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